Orthofix S R L

FDA Filings

This page includes the latest FDA filings for Orthofix S R L. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9680825
• FEI Number: 3002807827
• Name: ORTHOFIX SRL
• Owner & Operator: ORTHOFIX SRL
• Contact Address: VIA DELLE NAZIONI 9 --; BUSSOLENGO IT-VR Verona 37012 IT
• Official Correspondent:
  • GIANLUCA - RICADONA
  • 39-045-6719000-x
• US Agent:
  • Debbie Smith
  • ORTHOFIX INC.
  • 214 9372000
  • DebbieSmith@Orthofix.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: VIA DELLE NAZIONI 9 ; BUSSOLENGO Verona, 37012 IT
• Establishment Type:
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 18059015376753 ORTHOFIX SRL	TRUELOK SYSTEM 50-2517	2025-07-22
GUDID 18059015376746 ORTHOFIX SRL	TRUELOK SYSTEM 50-2516	2025-07-22
GUDID 18059015376739 ORTHOFIX SRL	TRUELOK SYSTEM 50-2515	2025-07-22
GUDID 18059015376111 ORTHOFIX SRL	Fitbone Trochanteric 99-O4OL18B10	2025-07-22
GUDID 18053504363774 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-24222	2025-06-17
GUDID 18053504363767 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-24220	2025-06-17
GUDID 18053504363750 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-24218	2025-06-17
GUDID 18053504363743 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-24216	2025-06-17
GUDID 18053504363736 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-24214	2025-06-17
GUDID 18053504363729 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-24212	2025-06-17
GUDID 18053504363712 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-24210	2025-06-17
GUDID 18053504363705 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-24208	2025-06-17
GUDID 18053504363699 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24240	2025-06-17
GUDID 18053504363682 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24238	2025-06-17
GUDID 18053504363675 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24236	2025-06-17
GUDID 18053504363668 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24234	2025-06-17
GUDID 18053504363651 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24232	2025-06-17
GUDID 18053504363644 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24230	2025-06-17
GUDID 18053504363637 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24228	2025-06-17
GUDID 18053504363620 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24226	2025-06-17
GUDID 18053504363613 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24224	2025-06-17
GUDID 18053504363606 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24222	2025-06-17
GUDID 18053504363590 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24220	2025-06-17
GUDID 18053504363583 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24218	2025-06-17
GUDID 18053504363576 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24216	2025-06-17
GUDID 18053504363569 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24214	2025-06-17
GUDID 18053504363552 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24212	2025-06-17
GUDID 18053504363545 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24210	2025-06-17
GUDID 18053504363538 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-24208	2025-06-17
GUDID 18053504363521 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24240	2025-06-17
GUDID 18053504363514 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24238	2025-06-17
GUDID 18053504363507 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24236	2025-06-17
GUDID 18053504363491 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24234	2025-06-17
GUDID 18053504363484 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24232	2025-06-17
GUDID 18053504363477 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24230	2025-06-17
GUDID 18053504363460 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24228	2025-06-17
GUDID 18053504363453 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24226	2025-06-17
GUDID 18053504363446 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24224	2025-06-17
GUDID 18053504363439 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24222	2025-06-17
GUDID 18053504363422 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24220	2025-06-17
GUDID 18053504363415 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24218	2025-06-17
GUDID 18053504363408 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24216	2025-06-17
GUDID 18053504363392 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24214	2025-06-17
GUDID 18053504363385 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24212	2025-06-17
GUDID 18053504363378 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24210	2025-06-17
GUDID 18053504363361 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-L-24208	2025-06-17
GUDID 18053504363354 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20240	2025-06-17
GUDID 18053504363347 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20238	2025-06-17
GUDID 18053504363330 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20236	2025-06-17
GUDID 18053504363323 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20234	2025-06-17
GUDID 18053504363316 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20232	2025-06-17
GUDID 18053504363309 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20230	2025-06-17
GUDID 18053504363293 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20228	2025-06-17
GUDID 18053504363286 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20226	2025-06-17
GUDID 18053504363279 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20224	2025-06-17
GUDID 18053504363262 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20222	2025-06-17
GUDID 18053504363255 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20220	2025-06-17
GUDID 18053504363248 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20218	2025-06-17
GUDID 18053504363231 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20216	2025-06-17
GUDID 18053504363224 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20214	2025-06-17
GUDID 18053504363217 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20212	2025-06-17
GUDID 18053504363200 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20210	2025-06-17
GUDID 18053504363194 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-N-20208	2025-06-17
GUDID 18053504363187 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20240	2025-06-17
GUDID 18053504363170 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20238	2025-06-17
GUDID 18053504363163 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20236	2025-06-17
GUDID 18053504363156 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20234	2025-06-17
GUDID 18053504363149 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20232	2025-06-17
GUDID 18053504363132 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20230	2025-06-17
GUDID 18053504363125 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20228	2025-06-17
GUDID 18053504363118 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20226	2025-06-17
GUDID 18053504363101 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20224	2025-06-17
GUDID 18053504363095 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20222	2025-06-17
GUDID 18053504363088 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20220	2025-06-17
GUDID 18053504363071 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20218	2025-06-17
GUDID 18053504363064 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20216	2025-06-17
GUDID 18053504363057 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20214	2025-06-17
GUDID 18053504363040 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20212	2025-06-17
GUDID 18053504363033 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20210	2025-06-17
GUDID 18053504363026 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 102-L-20208	2025-06-17
GUDID 18053504363019 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20240	2025-06-17
GUDID 18053504363002 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20238	2025-06-17
GUDID 18053504362999 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20236	2025-06-17
GUDID 18053504362982 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20234	2025-06-17
GUDID 18053504362975 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20232	2025-06-17
GUDID 18053504362968 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20230	2025-06-17
GUDID 18053504362951 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20228	2025-06-17
GUDID 18053504362944 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20226	2025-06-17
GUDID 18053504362937 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20224	2025-06-17
GUDID 18053504362920 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20222	2025-06-17
GUDID 18053504362913 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20220	2025-06-17
GUDID 18053504362906 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20218	2025-06-17
GUDID 18053504362890 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20216	2025-06-17
GUDID 18053504362883 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20214	2025-06-17
GUDID 18053504362876 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20212	2025-06-17
GUDID 18053504362869 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20210	2025-06-17
GUDID 18053504362852 ORTHOFIX SRL	VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-N-20208	2025-06-17
GUDID 18052469476406 ORTHOFIX SRL	MINI-FIXATION SYSTEMS 99-M1460	2025-06-17
GUDID 18052469476086 ORTHOFIX SRL	MINI-FIXATION SYSTEMS 99-M146	2025-06-17
GUDID 18052469476055 ORTHOFIX SRL	MINI-FIXATION SYSTEMS M146	2025-06-17
PMN K213572 Orthofix Srl	JuniOrtho Plating System™	2022-01-18
PMN K212044 Orthofix SRL	TrueLok Evo	2021-11-05
PMN K210157 Orthofix SRL	SOLE Medial Column Fusion Plate	2021-04-20
PMN K200246 Orthofix Srl	JPS JuniOrtho Plating System	2020-05-22
JDX ORTHOFIX SRL	OSCAR PRO	2020-03-12
PMN K190388 | HWC ORTHOFIX SRL	RIVALTM View Plating System? and Reduce Fracture Plating System?	2019-06-10
PMN K190388 | HRS ORTHOFIX SRL	RIVALTM View Plating System? and Reduce Fracture Plating System?	2019-06-10
PMN K190388 Orthofix Srl	RIVAL View Plating Systems And Reduce Fracture Plating Systems	2019-06-07
PMN K180624 | OBT ORTHOFIX SRL	Guided Growth Plate System Plus	2018-05-16
PMN K180624 Orthofix Srl	Guided Growth Plate System Plus	2018-05-15
PMN K051053 | LZV ORTHOFIX SRL	OSCAR	2018-05-11
PMN K051053 | LZV ORTHOFIX SRL	OSCAR, MODEL OE3000DB	2018-05-11
PMN K051053 | JDX ORTHOFIX SRL	OSCAR	2018-05-11
PMN K051053 | JDX ORTHOFIX SRL	OSCAR, MODEL OE3000DB	2018-05-11
PMN K021502 | LZV ORTHOFIX SRL	OSCAR	2018-05-11
PMN K021502 | LZV ORTHOFIX SRL	OSCAR, MODEL OE3000	2018-05-11
PMN K172699 | HSB ORTHOFIX SRL	Agile Nail	2018-04-24
PMN K172699 Orthofix Srl	Agile Nail	2018-04-23
PMN K172698 | HWC ORTHOFIX SRL	G-Beam Fusion Beaming System	2018-03-06
PMN K172698 Orthofix Srl	G-Beam Fusion Beaming System	2018-02-07
PMN K172183 | OBT ORTHOFIX SRL	Guided Growth Plate System	2018-01-10
PMN K172183 | OBT ORTHOFIX SRL	Guided Growth Plate System Plus	2018-01-10
PMN K172183 Orthofix Srl	Guided Growth Plate System Plus	2018-01-09
PMN K173458 | HSB ORTHOFIX SRL	ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System	2017-12-14
PMN K173458 | HSB ORTHOFIX SRL	Chimaera Hip Fracture System	2017-12-14
PMN K173458 Orthofix Srl	ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System	2017-12-07
PMN K173051 | HWC ORTHOFIX SRL	Orthofix MJ-FLEX THE NEW METAIZEAU NAIL	2017-11-17
PMN K173051 | HWC ORTHOFIX SRL	MJ-Flex	2017-11-17
PMN K173051 | HTY ORTHOFIX SRL	Orthofix MJ-FLEX THE NEW METAIZEAU NAIL	2017-11-17
PMN K173051 | HTY ORTHOFIX SRL	MJ-Flex	2017-11-17
PMN K173051 Orthofix Srl	Orthofix MJ-FLEX THE NEW METAIZEAU NAIL	2017-11-16
PMN K170146 | KTT ORTHOFIX SRL	Galaxy UNYCO System	2017-10-30
PMN K170146 | KTT ORTHOFIX SRL	Galaxy UNYCO Femur&Knee Bridging	2017-10-30
PMN K170146 Orthofix Srl	Galaxy UNYCO System	2017-10-12
PMN K132893 | HWC ORTHOFIX SRL	Rival Bite Compression Screws	2017-06-15
PMN K142135 | HRS ORTHOFIX SRL	Rival View Plating System	2017-06-06
PMN K142135 | HRS ORTHOFIX SRL	Rival Reduce Fracture Plating System	2017-06-06
PMN K140876 | HWC ORTHOFIX SRL	Rival View Plating System	2017-06-06
PMN K140876 | HWC ORTHOFIX SRL	Rival Reduce Fracture Plating System	2017-06-06
PMN K140876 | HRS ORTHOFIX SRL	Rival View Plating System	2017-06-06
PMN K140876 | HRS ORTHOFIX SRL	Rival Reduce Fracture Plating System	2017-06-06
PMN K170650 | OSN ORTHOFIX SRL	True Lok System	2017-05-11
PMN K170650 | OSN ORTHOFIX SRL	Orthofix TrueLok Hexapod System (TL-HEX) V2.0	2017-05-11
PMN K170650 | KTT ORTHOFIX SRL	True Lok System	2017-05-11
PMN K170650 | KTT ORTHOFIX SRL	Orthofix TrueLok Hexapod System (TL-HEX) V2.0	2017-05-11
PMN K170650 Orthofix Srl	Orthofix TrueLok Hexapod System (TL-HEX) V2.0	2017-05-10
PMN K161466 | HSB ORTHOFIX SRL	Orthofix Chimaera Hip Fracture System - Trochanteric Nailing System	2017-01-25
PMN K161466 | HSB ORTHOFIX SRL	Chimaera Hip Fracture System	2017-01-25
PMN K161466 ORTHOFIX SRL	ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System	2017-01-24
PMN K093805 | LZV ORTHOFIX SRL	OSCAR 3	2016-12-13
PMN K093805 | JDX ORTHOFIX SRL	OSCAR 3	2016-12-13
PMN K101936 | HWC ORTHOFIX SRL	Contours VPS Volar Plating System	2016-11-03
PMN K101936 | HWC ORTHOFIX SRL	Contours VPS III Volar Plating System (bone plate)	2016-11-03
PMN K101936 | HRS ORTHOFIX SRL	Contours VPS Volar Plating System	2016-11-03
PMN K101936 | HRS ORTHOFIX SRL	Contours VPS III Volar Plating System (bone plate)	2016-11-03
PMN K042766 | HRS ORTHOFIX SRL	Orthofix Volar Distal Radial Plate	2016-11-03
PMN K042766 | HRS ORTHOFIX SRL	Contours VPS Volar Plating System	2016-11-03
PMN K102201 | HRS ORTHOFIX SRL	Contours Lapidus Plating System	2016-02-24
PMN K153233 | KTT ORTHOFIX SRL	Galaxy UNYCO	2016-01-11
PMN K153233 | KTT ORTHOFIX SRL	Galaxy UNYCO System	2016-01-11
PMN K153233 ORTHOFIX SRL	Galaxy UNYCO System	2016-01-06
PMN K110805 | OBT ORTHOFIX SRL	GUIDED GROWTH SYSTEM EIGHT PLATE, QUAD-PLATE (STAINLESS STEEL)	2015-11-06
PMN K110805 | OBT ORTHOFIX SRL	GUIDED GROWTH PLATE SYSTEM	2015-11-06
PMN K093442 | OBT ORTHOFIX SRL	GUIDED GROWTH SYSTEM	2015-11-06
PMN K093442 | OBT ORTHOFIX SRL	GUIDED GROWTH PLATE SYSTEM	2015-11-06
PMN K152171 ORTHOFIX SRL	Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4	2015-09-28
PMN K141571 | HSB ORTHOFIX SRL	ANKLE HINDFOOT NAILING SYSTEM	2015-08-27
PMN K141571 | HSB ORTHOFIX SRL	ANKLE COMPRESSION NAILING SYSTEM	2015-08-27
PMN K142052 | KTT ORTHOFIX SRL	GALAXY UNYCO	2014-12-11
PMN K142052 | KTT ORTHOFIX SRL	GALAXY UNYCO DIAPHYSEAL TIBIA KIT	2014-12-11
PMN K141760 | KTT ORTHOFIX SRL	GALAXY WRIST	2014-12-11
PMN K141760 | KTT ORTHOFIX SRL	GALAXY FIXATION SYSTEM	2014-12-11
PMN K143125 Orthofix Srl	Orthofix True Lok Hexapod System VI.3	2014-12-10
PMN K141760 ORTHOFIX SRL	ORTHOFIX GALAXY WRIST	2014-12-08
PMN K142052 ORTHOFIX SRL	ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT	2014-12-05
PMN K141571 ORTHOFIX SRL	ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM	2014-11-12
PMN K141078 ORTHOFIX SRL	ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)	2014-09-02
PMN K122541 | KTW ORTHOFIX SRL	CONTOURS PROXIMAL HUMERAL PLATE (PHP)	2013-01-21
PMN K031493 | HRS ORTHOFIX SRL	GUIDED GROWTH PLATE	2012-09-24
PMN K031493 | HRS ORTHOFIX SRL	GUIDED GROWTH PLATE SYSTEM	2012-09-24
PMN K122541 ORTHOFIX SRL	ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)	2012-09-20
PMN K113770 | KTT ORTHOFIX SRL	GALAXY FIXATION SYSTEM	2012-09-14
PMN K113770 ORTHOFIX SRL	ORTHOFIX GALAXY FIXATION SYSTEM	2012-09-04
PMN K941048 | LXT ORTHOFIX SRL	TRUE LOK SYSTEM	2010-12-27
PMN K941048 | LXT ORTHOFIX SRL	TRUE LOK PLUS SYSTEM	2010-12-27
PMN K974186 | JDW ORTHOFIX SRL	HA BONE SCREWS	2007-12-21
PMN K961027 | HSB ORTHOFIX SRL	STAINLESS STEEL TIBIAL NAILING SYSTEM	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	XCALIBER EXTERNAL FIXATOR	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	XCALIBER BONE SCREWS	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	TITANIUM SCREWS	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	SMALL BLUE D.A.F.	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	RADIOLUCENT WRIST FIXATOR	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	PROCALLUS FIXATOR	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	PREFIX FIXATOR	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	PERTROCHANTERIC FIXATOR	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	PENNIG MINIFIXATOR	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	PENNIG DYNAMIC WRIST FIXATOR	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	PELVIC FIXATOR	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	PAEDIATRIC LIMB RECONSTRUCTION SYSTEM	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	MINIRAIL SYSTEM	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	ELBOW FIXATOR	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	DYNAMIC AXIAL FIXATOR	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	BONE SCREWS	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	ADVANCED LIMB RECONSTRUCTION SYSTEM	2007-12-21
PMN K955848 | JDW ORTHOFIX SRL	ADULT LIMB RECONSTRUCTION SYSTEM	2007-12-21
PMN K944092 | JEC ORTHOFIX SRL	SHEFFIELD RING FIXATOR	2007-12-21
PMN K944092 | JEC ORTHOFIX SRL	HYBRID FIXATOR SYSTEM	2007-12-21
PMN K944092 | JEC ORTHOFIX SRL	FRAGMENT FIXATION SYSTEM	2007-12-21
PMN K062920 | KTW ORTHOFIX SRL	LSP TITANIUM HUMERAL PLATE	2007-12-21
HTO ORTHOFIX SRL	FLEXIBLE REAMER	2007-05-14
HTO ORTHOFIX SRL	FLEXIBLE REAMER SYSTEM	2007-05-14
PMN K983814 | JDO ORTHOFIX SRL	PERCUTANEOUS COMPRESSION PLATE (PC.CP)	2007-02-13
HST ORTHOFIX SRL	PORD DEVICE	2007-02-13
PMN K062920 ORTHOFIX SRL	ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP	2006-11-13
PMN K053261 ORTHOFIX SRL	ORTHOFIX TITANIUM NAILING SYSTEMS	2005-12-12
PMN K051945 | HRS ORTHOFIX SRL	MIOT PLATING SYSTEM	2005-11-25
PMN K051945 ORTHOFIX SRL	MIOT PLATING SYSTEM	2005-09-06
LXH ORTHOFIX SRL	Orthofix Rival Orthopedic Surgical Instruments	2000-04-06
LXH ORTHOFIX SRL	Orthofix Orthopedic Surgical Instruments	2000-04-06
PMN K974186 ORTHOFIX SRL	ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING	1998-03-18
PMN K973944 ORTHOFIX SRL	ORTHOFIX FEMORAL NAILING SYTEM	1997-12-19
PMN K944092 ORTHOFIX SRL	ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM	1995-04-04

Similar & Related FDA Registered Companies

• Orthofix, Inc.3451 Plano Parkwaylewisville, TX 75056 PMA NumberP030034 Supplement NumberS017 Date Received03/16/2022 Decision Date06/14/2022 Product Code LOF  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Orthofix, Inc.3451 Plano Parkwaylewisville, TX 75056 PMA NumberP850007 Supplement NumberS046 Date Received03/16/2022 Decision Date06/14/2022 Product Code LOF  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Orthofix US LLC3451 Plano Parkwaylewisville, TX 75056 PMA NumberP210035 Date Received10/13/2021 Decision Date05/03/2022 Product Code LOF  Advisory Committee Orthopedic Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	A5947	ORTHOFIX SRL
CAGE Code	A5947	ORTHOFIX SRL