Biomet

FDA Filings

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

FDA Registration(s)

• Registration Number: 3003506715
• FEI Number: 3003506715
• Name: Biomet
• Owner & Operator: Biomet, Inc.
• Contact Address: 56 East Bell Dr. PO Box 587; Warsaw IN 46582 US
• Official Correspondent:
  • Steven C de Baca
  • 1-574-3773437-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 6303 Blue Lagoon Drive Suite 100; Miami, FL 33126 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID 07350023771719 BIOMET	Cement Delivery System 4146	2021-05-05
GUDID 08428898898349 BIOMET	TESS TOP INSERT HEMI A1700386	2020-10-21
GUDID 08428898898332 BIOMET	TESS BOTTOM INSERT HEMI A1700384	2020-10-21
GUDID 03599870108505 BIOMET	T.E.S.S® LID A1700382	2020-10-21
GUDID 03599870107898 BIOMET	TESS BASE A1700380	2020-10-21
GUDID 70880304810999 BIOMET	Cement Delivery System 110030623	2020-04-23
GUDID 07350023771092 BIOMET	Optivac Nozzle Slim 4154	2019-10-21
PMN K173767 | HRS Biomet [Biomet, Inc.]	A. L. P. S. Clavicle Plating System	2019-01-11
PMN K042059 | LXT Biomet [Biomet, Inc.]	SHOULDER FIXATION SYSTEM	2018-12-14
PMN K980370 | KTT Biomet [Biomet, Inc.]	BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR	2018-11-05
PMN K874672 | HWC Biomet [Biomet, Inc.]	ACE CORTICAL LAG SCREW	2018-11-05
PMN K041081 | KTT Biomet [Biomet, Inc.]	FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES	2018-11-05
GUDID 00887868214608 BIOMET	BIOMET® BONE CEMENT R 110035371	2018-07-06
GUDID 00887868214578 BIOMET	BIOMET® BONE CEMENT R 110035368	2018-07-06
GUDID 00880304990227 BIOMET	REFOBACIN® BONE CEMENT R 110034358	2018-07-06
GUDID 00880304990210 BIOMET	REFOBACIN® BONE CEMENT R 110034357	2018-07-06
GUDID 00880304990203 BIOMET	REFOBACIN® BONE CEMENT R 110034356	2018-07-06
GUDID 00880304990197 BIOMET	REFOBACIN® BONE CEMENT R 110034355	2018-07-06
GUDID 07350023771429 BIOMET	ANGLED NOZZLE 4149	2018-03-29
GUDID 07350023771214 BIOMET	CEMENTATION NOZZLE 4312	2018-03-29
GUDID 07350023771108 BIOMET	OPTIVAC NOZZLE REVISION 4155	2018-03-29
GUDID 00880304488380 BIOMET	OPTIVAC FUSION 419000	2018-03-29
GUDID 00880304371002 BIOMET	OPTIVAC KIT, 120 GRAM TRIPLE MIX 418300	2018-03-29
GUDID 00880304370999 BIOMET	OPTIVAC KIT, 80 GRAM DOUBLE MIX 418200	2018-03-29
GUDID 00880304370647 BIOMET	OPTIVAC TOTAL HIP KIT 418000	2018-03-29
GUDID 00880304370623 BIOMET	OPTIVAC KIT, 120 GRAM TRIPLE MIX 417300	2018-03-29
GUDID 00880304370609 BIOMET	OPTIVAC KIT, 80 GRAM DOUBLE MIX 417200	2018-03-29
GUDID 00880304370579 BIOMET	OPTIVAC KIT, 40 GRAM SINGLE MIX 417100	2018-03-29
GUDID 00880304370562 BIOMET	OPTIVAC TOTAL HIP KIT 417000	2018-03-29
GUDID 00880304370326 BIOMET	RIGHT-ANGLE NOZZLE 414900	2018-03-29
PMN K162424 | HRS Biomet [Biomet, Inc.]	Ulna Plating System	2016-11-09
PMN K160058 | HWC Biomet [Biomet, Inc.]	Biomet Variable Pitch Compression Screw System	2016-03-22
PMN K081244 | KTT Biomet [Biomet, Inc.]	LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS	2015-10-15
PMN K143697 | HRS Biomet [Biomet, Inc.]	Biomet Proximal Humerus Plating System	2015-04-17
PMN K133939 | HRS Biomet [Biomet, Inc.]	PLATING SYSTEM	2014-08-05
PMN K133939 | HRS Biomet [Biomet, Inc.]	MODIFIED DISTAL RADIUS	2014-08-05
PMN K140622 | HRS Biomet [Biomet, Inc.]	DVR ULNA PLATE	2014-07-30
PMN K140622 | HRS Biomet [Biomet, Inc.]	DVR LATERAL PLATE	2014-07-30
PMN K140622 | HRS Biomet [Biomet, Inc.]	DVR DORSAL PLATE	2014-07-30
HTY Biomet [Biomet, Inc.]	pin, fixation, smooth	2014-04-14
HTY Biomet [Biomet, Inc.]	Osteo Tutor	2014-04-14
PMN K132704 | LXT Biomet [Biomet, Inc.]	DISTAL RADIUS VOLAR RIM PLATE STANDARD AND NARROW	2014-03-28
PMN K131867 | HRS Biomet [Biomet, Inc.]	2.5MM INLINE FUSION PLATE	2014-03-27
PMN K131670 | HRS Biomet [Biomet, Inc.]	LAPIDUS PLATE,	2013-09-11
PMN K131670 | HRS Biomet [Biomet, Inc.]	3.5MM MTP PLATE (LEFT AND RIGHT)	2013-09-11
PMN K131670 | HRS Biomet [Biomet, Inc.]	3.5MM INLINE FUSION PLATE	2013-09-11
HWD Biomet [Biomet, Inc.]	BIOMET BONE SCREW STARTER	2013-01-27
PMN K090877 | HWC Biomet [Biomet, Inc.]	PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW	2012-07-10
PMN K090877 | HWC Biomet [Biomet, Inc.]	PROFILE AND MULTIDIRECTIONAL SCREWS	2012-07-10
PMN K090877 | HRS Biomet [Biomet, Inc.]	PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW	2012-07-10
PMN K090877 | HRS Biomet [Biomet, Inc.]	PROFILE AND MULTIDIRECTIONAL SCREWS	2012-07-10
PMN K083843 | HRS Biomet [Biomet, Inc.]	LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM	2012-07-10
PMN K993465 | HRS Biomet [Biomet, Inc.]	DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE	2012-06-18
PMN K990120 | HSB Biomet [Biomet, Inc.]	MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE	2012-06-18
PMN K984458 | HTN Biomet [Biomet, Inc.]	DEPUY ACE SPIDER PLATE	2012-06-18
PMN K984458 | HRS Biomet [Biomet, Inc.]	DEPUY ACE SPIDER PLATE	2012-06-18
PMN K983853 | HRS Biomet [Biomet, Inc.]	DEPUY ACE TIMAX META PLATE	2012-06-18
PMN K981775 | HRS Biomet [Biomet, Inc.]	DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE	2012-06-18
PMN K954485 | HWC Biomet [Biomet, Inc.]	6.5MM SOLID CANCELLOUS BONE SCREW	2012-06-18
PMN K926047 | HWC Biomet [Biomet, Inc.]	ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW	2012-06-18
PMN K905774 | HRS Biomet [Biomet, Inc.]	THACKRAY TITANIUM MINI-PLATING SYSTEM	2012-06-18
PMN K905048 | HWC Biomet [Biomet, Inc.]	ACE 3.5MM CORTICAL BONE SCREW	2012-06-18
PMN K903811 | HWC Biomet [Biomet, Inc.]	ACE CANNULATED CORTICAL BONE SCREW	2012-06-18
PMN K903810 | HWC Biomet [Biomet, Inc.]	ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW	2012-06-18
PMN K874670 | HWC Biomet [Biomet, Inc.]	ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW	2012-06-18
PMN K872859 | HWC Biomet [Biomet, Inc.]	ACE CANCELLOUS BONE SCREW	2012-06-18
PMN K782123 | HRS Biomet [Biomet, Inc.]	MULTIPLICITY OF PRODUCTS	2012-06-18
PMN K112345 | LXT Biomet [Biomet, Inc.]	DISTAL VOLAR RADIUS PLATING SYSTEMS	2012-06-18
PMN K111663 | LXT Biomet [Biomet, Inc.]	TRAUMA INTERNAL FIXATION SYSTEMS	2012-06-18
PMN K111663 | KTT Biomet [Biomet, Inc.]	TRAUMA INTERNAL FIXATION SYSTEMS	2012-06-18
PMN K111663 | JDW Biomet [Biomet, Inc.]	TRAUMA INTERNAL FIXATION SYSTEMS	2012-06-18
PMN K111663 | HWC Biomet [Biomet, Inc.]	TRAUMA INTERNAL FIXATION SYSTEMS	2012-06-18
PMN K111663 | HTY Biomet [Biomet, Inc.]	TRAUMA INTERNAL FIXATION SYSTEMS	2012-06-18
PMN K111663 | HTN Biomet [Biomet, Inc.]	TRAUMA INTERNAL FIXATION SYSTEMS	2012-06-18
PMN K111663 | HSB Biomet [Biomet, Inc.]	TRAUMA INTERNAL FIXATION SYSTEMS	2012-06-18
PMN K111663 | HRS Biomet [Biomet, Inc.]	TRAUMA INTERNAL FIXATION SYSTEMS	2012-06-18
PMN K103408 | HRS Biomet [Biomet, Inc.]	POSTERIOR LATERAL PLATES	2012-06-18
PMN K103001 | JDW Biomet [Biomet, Inc.]	ROCKWOOD CLAVICLE PINS	2012-06-18
PMN K101421 | HWC Biomet [Biomet, Inc.]	OLECRANON PLATES MODEL 131218704-708; 851318704-708, 1312182	2012-06-18
PMN K101421 | HWC Biomet [Biomet, Inc.]	MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES,	2012-06-18
PMN K101421 | HTN Biomet [Biomet, Inc.]	OLECRANON PLATES MODEL 131218704-708; 851318704-708, 1312182	2012-06-18
PMN K101421 | HTN Biomet [Biomet, Inc.]	MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES,	2012-06-18
PMN K101421 | HRS Biomet [Biomet, Inc.]	OLECRANON PLATES MODEL 131218704-708; 851318704-708, 1312182	2012-06-18
PMN K101421 | HRS Biomet [Biomet, Inc.]	MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES,	2012-06-18
PMN K101240 | HRS Biomet [Biomet, Inc.]	CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021	2012-06-18
PMN K101240 | HRS Biomet [Biomet, Inc.]	824677021, 22, 824071001, 824071101, 824671001, 82467	2012-06-18
PMN K093474 | HWC Biomet [Biomet, Inc.]	DEPUY FRACTURE AND FUSION PLATING SYSTEM	2012-06-18
PMN K093474 | HRS Biomet [Biomet, Inc.]	DEPUY FRACTURE AND FUSION PLATING SYSTEM	2012-06-18
PMN K091294 | HWC Biomet [Biomet, Inc.]	PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,	2012-06-18
PMN K091294 | HWC Biomet [Biomet, Inc.]	LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSIO	2012-06-18
PMN K091294 | HRS Biomet [Biomet, Inc.]	PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,	2012-06-18
PMN K091294 | HRS Biomet [Biomet, Inc.]	LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSIO	2012-06-18
PMN K090374 | LXT Biomet [Biomet, Inc.]	STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S	2012-06-18
PMN K090374 | LXT Biomet [Biomet, Inc.]	131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S	2012-06-18
PMN K083364 | HWC Biomet [Biomet, Inc.]	2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-	2012-06-18
PMN K083364 | HWC Biomet [Biomet, Inc.]	131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424	2012-06-18
PMN K083364 | HRS Biomet [Biomet, Inc.]	2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-	2012-06-18
PMN K083364 | HRS Biomet [Biomet, Inc.]	131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424	2012-06-18
PMN K082300 | HWC Biomet [Biomet, Inc.]	ANATOMIC LOCKING PLATING SYSTEM	2012-06-18
PMN K082300 | HTN Biomet [Biomet, Inc.]	ANATOMIC LOCKING PLATING SYSTEM	2012-06-18
PMN K082300 | HRS Biomet [Biomet, Inc.]	ANATOMIC LOCKING PLATING SYSTEM	2012-06-18
PMN K081546 | HRS Biomet [Biomet, Inc.]	SMALL BONE LOCKING PLATING SYSTEM	2012-06-18
PMN K072832 | HRS Biomet [Biomet, Inc.]	ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM	2012-06-18
PMN K072423 | HRS Biomet [Biomet, Inc.]	CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY	2012-06-18
PMN K072423 | HRS Biomet [Biomet, Inc.]	4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5	2012-06-18
PMN K072083 | HRS Biomet [Biomet, Inc.]	SMALL FRAGMENT LOCKING PLATING SYSTEM	2012-06-18
PMN K061748 | KTT Biomet [Biomet, Inc.]	FRAGMENT PLATE SYSTEM	2012-06-18
PMN K060969 | HRS Biomet [Biomet, Inc.]	POLYAX LOCKED PLATING SYSTEM	2012-06-18
PMN K060864 | LXT Biomet [Biomet, Inc.]	MULTIDIRECTIONAL THREADED PEG	2012-06-18
PMN K060294 | HRS Biomet [Biomet, Inc.]	DIAPHYSEAL PLATE	2012-06-18
PMN K060290 | LXT Biomet [Biomet, Inc.]	SHOULDER FIXATION SYSTEM	2012-06-18
PMN K052294 | HRS Biomet [Biomet, Inc.]	SHOULDER NAIL PLATE	2012-06-18
PMN K052248 | HRS Biomet [Biomet, Inc.]	DORSAL NAIL PLATE, ANATOMICAL	2012-06-18
PMN K050932 | LXT Biomet [Biomet, Inc.]	DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM	2012-06-18
PMN K041157 | HTY Biomet [Biomet, Inc.]	MODIFICATION TO SMALL BONE FIXATION SYSTEM	2012-06-18
PMN K003235 | HRS Biomet [Biomet, Inc.]	PE.R.I. II KNEE FRACTURE SYSTEM	2012-06-18
PMN K972629 | KTT Biomet [Biomet, Inc.]	DEPUY AE TK2 HIP SCREW SYSTEM	2012-06-17
PMN K955472 | HRS Biomet [Biomet, Inc.]	ACE HUMERUS & RADIUS PLATES	2012-06-17
PMN K930592 | HRS Biomet [Biomet, Inc.]	ACE UNIVERSAL RECONSTRUCTION PLATE	2012-06-17
PMN K920738 | HRS Biomet [Biomet, Inc.]	ACE 100 DEGREES TUBULAR PLATE	2012-06-17
PMN K905595 | HRS Biomet [Biomet, Inc.]	ACE RECONSTRUCTIVE PLATE	2012-06-17
PMN K895107 | HTN Biomet [Biomet, Inc.]	ACE ORTHOPAEDIC WASHERS	2012-06-17
PMN K882831 | HWC Biomet [Biomet, Inc.]	ACE CANCELLOUS BONE SCREW	2012-06-17
PMN K040833 | KTT Biomet [Biomet, Inc.]	XFIX VISION FIXATION SYSTEM	2011-09-01
PMN K020141 | KTT Biomet [Biomet, Inc.]	EBI XFIX VISION FIXATION SYSTEM	2011-09-01
PMN K993886 | KTT Biomet [Biomet, Inc.]	EBI XFIX VISION FIXATION SYSTEM	2011-08-30
PMN K042237 | HRS Biomet [Biomet, Inc.]	EBI PERIARTICULAR PLATING SYSTEM	2011-08-30
PMN K020403 | KTT Biomet [Biomet, Inc.]	MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR	2011-08-30
PMN K014194 | KTT Biomet [Biomet, Inc.]	MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM	2011-08-30
PMN K951357 | KTT Biomet [Biomet, Inc.]	SMALL EXTERNAL FIXATOR (S/E/F/)	2011-08-25
PMN K030706 | HWC Biomet [Biomet, Inc.]	EBI DYNAFIX COMPRESSION BONE SCREW	2011-08-25
PMN K061098 | HWC Biomet [Biomet, Inc.]	EBI OPTILOCK PERIARTICULAR PLATING SYSTEM	2011-07-28
PMN K061098 | HRS Biomet [Biomet, Inc.]	EBI OPTILOCK PERIARTICULAR PLATING SYSTEM	2011-07-28
PMN K831005 | HTY Biomet [Biomet, Inc.]	WIRE & STEINMAN PINS	2011-05-25
LXH Biomet [Biomet, Inc.]	ORTHOPEDIC	2003-01-08
LXH Biomet [Biomet, Inc.]	MANUAL INSTRUMENT	2003-01-08
LXH Biomet [Biomet, Inc.]	BIOMET GENERAL	2003-01-08
FZX Biomet [Biomet, Inc.]	GUIDE	1998-08-27
FZX Biomet [Biomet, Inc.]	BIOMET SURGICIAL	1998-08-27
HTD Biomet [Biomet, Inc.]	BIOMET FORCEPS	1992-12-08
FSM Biomet [Biomet, Inc.]	SURGICAL INSTRUMENT	1992-12-08
FSM Biomet [Biomet, Inc.]	BIOMET TRAY,	1992-12-08
HTF Biomet [Biomet, Inc.]	BIOMET CURETTE	1991-07-15
HXX Biomet [Biomet, Inc.]	SCREWDRIVER	1978-03-22
HXX Biomet [Biomet, Inc.]	BIOMET	1978-03-22
HXC Biomet [Biomet, Inc.]	BIOMET WRENCH	1978-03-22
HYA Biomet [Biomet, Inc.]	HOLDING FORCEPS	1977-12-28
HYA Biomet [Biomet, Inc.]	BIOMET WIRE	1977-12-28
HXZ Biomet [Biomet, Inc.]	CUTTER	1977-12-28
HXZ Biomet [Biomet, Inc.]	BIOMET WIRE	1977-12-28
HXP Biomet [Biomet, Inc.]	INSTRUMENT	1977-12-28
HXP Biomet [Biomet, Inc.]	CONTOURING	1977-12-28
HXP Biomet [Biomet, Inc.]	BIOMET	1977-12-28
HXP Biomet [Biomet, Inc.]	BENDING AND	1977-12-28
HXG Biomet [Biomet, Inc.]	BIOMET TAMP	1977-12-28
HWX Biomet [Biomet, Inc.]	TAP	1977-12-28
HWX Biomet [Biomet, Inc.]	BIOMET BONE	1977-12-28
HWT Biomet [Biomet, Inc.]	BIOMET TEMPLATE	1977-12-28
HWR Biomet [Biomet, Inc.]	PROSTHESIS DRIVER	1977-12-28
HWR Biomet [Biomet, Inc.]	BIOMET	1977-12-28
HWA Biomet [Biomet, Inc.]	BIOMET IMPACTOR	1977-12-28
HTW Biomet [Biomet, Inc.]	BIOMET DRILL BIT	1977-12-28
HTJ Biomet [Biomet, Inc.]	Gauge Biomet Depth	1977-12-28
HTJ Biomet [Biomet, Inc.]	GAUGE	1977-12-28
HTJ Biomet [Biomet, Inc.]	BIOMET DEPTH	1977-12-28
HTC Biomet [Biomet, Inc.]	Zimmer	1977-12-28
HTC Biomet [Biomet, Inc.]	SURGICAL PLIERS	1977-12-28
HTC Biomet [Biomet, Inc.]	BIOMET	1977-12-28
GDJ Biomet [Biomet, Inc.]	SURGICAL CLAMP	1977-12-28
GDJ Biomet [Biomet, Inc.]	BIOMET	1977-12-28
GAD Biomet [Biomet, Inc.]	RETRACTOR	1977-12-28
GAD Biomet [Biomet, Inc.]	BIOMET	1977-12-28

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