Avalign Instruments Implants

FDA Filings

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

FDA Registration(s)

• Registration Number: 3006128100
• FEI Number: 3006128100
• Name: Avalign Instruments & Implants
• Owner & Operator: Avalign Instruments & Implants
• Contact Address: 8727 Clinton Park Drive --; Fort Wayne IN 46825 US
• Official Correspondent:
  • Douglas McKinley
  • x-260-4805264-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 8727 & 8414 Clinton Park Dr ; FORT WAYNE, IN 46825 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3026776
• FEI Number: 1000135253
• Name: VIPER TECHNOLOGIES, LLC.
• Owner & Operator: Avalign Instruments & Implants
• Contact Address: 8727 Clinton Park Drive --; Fort Wayne IN 46825 US
• Official Correspondent:
  • Douglas McKinley
  • x-260-4805264-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 15045 NE MASON ST. ; PORTLAND, OR 97230 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K190122 | OIY VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Femoral Components	2019-08-19
PMN K190122 | JWH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Femoral Components	2019-08-19
PMN K141676 | LPH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Porous Shell Dome Hole Plug	2019-08-19
PMN K132312 | LPH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Dome Hole Plug	2019-08-19
PMN K131354 | KWY VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Femoral Heads	2019-08-19
PMN K120038 | OIY VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Femoral Components & Tibial Baseplates	2019-08-19
PMN K120038 | JWH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Femoral Components & Tibial Baseplates	2019-08-19
PMN K112897 | OQI VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Bone Screws	2019-08-19
PMN K112897 | OQG VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Bone Screws	2019-08-19
PMN K112897 | LZO VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Bone Screws	2019-08-19
PMN K112897 | LPH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Bone Screws	2019-08-19
PMN K113296 | LZO Avalign Instruments & Implants	ZMR Hip System	2019-08-13
PMN K113296 | LWJ Avalign Instruments & Implants	ZMR Hip System	2019-08-13
PMN K113296 | LPH Avalign Instruments & Implants	ZMR Hip System	2019-08-13
PMN K113296 | KWZ Avalign Instruments & Implants	ZMR Hip System	2019-08-13
PMN K113296 | JDI Avalign Instruments & Implants	ZMR Hip System	2019-08-13
PMN K111039 | HWC Avalign Instruments & Implants	Radial Styloid LK Plate 00235852703, 00235852705, 0023585252803, 00235852805	2019-03-26
PMN K111039 | HRS Avalign Instruments & Implants	Radial Styloid LK Plate 00235852703, 00235852705, 0023585252803, 00235852805	2019-03-26
PMN K181184 | HSB VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Intramedullary Nail System	2018-12-06
PMN K150121 | HRS Avalign Instruments & Implants	234850716 DISTAL SM MEDIAL HUM PLT 16 H	2018-11-28
PMN K150121 | HRS Avalign Instruments & Implants	234850714 DISTAL SM MEDIAL HUM PLT 14 H	2018-11-28
PMN K150121 | HRS Avalign Instruments & Implants	234850712 DISTAL SM MEDIAL HUM PLT 12 H	2018-11-28
PMN K142579 | HRS Avalign Instruments & Implants	234753600 REG LAT CALCANEAL PLT LT	2018-11-28
PMN K142579 | HRS Avalign Instruments & Implants	234753500 REG LAT CALCANEAL PLT RT	2018-11-28
PMN K142281 | HSB Avalign Instruments & Implants	PROX TARGETING GUIDE HUMERAL 225550400	2018-11-28
PMN K142281 | HSB Avalign Instruments & Implants	PROX TARGETING GDE TIBIAL 225550300	2018-11-28
PMN K142281 | HSB Avalign Instruments & Implants	MDN OBLIQUE HOLE ADAPTOR HUM 225550401	2018-11-28
PMN K091566 | HSB Avalign Instruments & Implants	STD CM FLEX CAPT SET SCREWDRIVER 00249003507	2018-11-28
PMN K091566 | HSB Avalign Instruments & Implants	SMALL CM FLEX CAPT SET SC 00249003506	2018-11-28
PMN K051098 | HWC Avalign Instruments & Implants	235852805 RADIAL STYLOID LOCKING PLATE 5H LT	2018-11-28
PMN K051098 | HWC Avalign Instruments & Implants	235852803 RADIAL STYLOID LOCKING PLATE 3H LT	2018-11-28
PMN K051098 | HWC Avalign Instruments & Implants	235852705 RADIAL STYLOID LOCKING PLATE 5H RT	2018-11-28
PMN K051098 | HWC Avalign Instruments & Implants	235852703 21DIAL STYLOID LOCKING PLATE 3H RT	2018-11-28
PMN K051098 | HRS Avalign Instruments & Implants	235852805 RADIAL STYLOID LOCKING PLATE 5H LT	2018-11-28
PMN K051098 | HRS Avalign Instruments & Implants	235852803 RADIAL STYLOID LOCKING PLATE 3H LT	2018-11-28
PMN K051098 | HRS Avalign Instruments & Implants	235852705 RADIAL STYLOID LOCKING PLATE 5H RT	2018-11-28
PMN K051098 | HRS Avalign Instruments & Implants	235852703 21DIAL STYLOID LOCKING PLATE 3H RT	2018-11-28
KIH Avalign Instruments & Implants	Power-Flo Cement Injector 506950800	2018-11-28
KIH Avalign Instruments & Implants	Miller Ratchet Injector 506950600	2018-11-28
PMN K953337 | LPH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	HIP, Prosthesis	2017-12-29
PMN K142649 | JWH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Prosthesis, Knee	2017-12-29
PMN K121297 | MEH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Hip, prosthesis	2017-12-29
PMN K121297 | LPH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Hip, prosthesis	2017-12-29
PMN K092748 | HWC VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Rod, Fixation, Intramedullary Screw, Fixation, Bone	2017-12-29
PMN K092748 | HSB VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Rod, Fixation, Intramedullary Screw, Fixation, Bone	2017-12-29
PMN K983766 | EZX Avalign Instruments & Implants	Synthes Synmesh	2017-04-13
HXQ Avalign Instruments & Implants	crimper, pin	2017-04-13
HXL Avalign Instruments & Implants	Mallet	2017-04-13
GEA Avalign Instruments & Implants	Cannula, Surgical, General & Plastic Surgery	2017-04-13
GDZ Avalign Instruments & Implants	Handle, Scalpel	2017-04-13
GFG Avalign Instruments & Implants	FLEXIBLE DRILL SCREW II SHAFT MODULAR	2015-09-23
PMN K112717 | IKN Avalign Instruments & Implants	NuVasive NVJJB System	2014-01-07
PMN K112717 | GWF Avalign Instruments & Implants	NuVasive NVJJB System	2014-01-07
PMN K112717 | ETN Avalign Instruments & Implants	NuVasive NVJJB System	2014-01-07
PMN K112709 | ETN Avalign Instruments & Implants	Stimulation instrument	2014-01-07
PMN K092287 | NKB Avalign Instruments & Implants	Armada Spinal System	2014-01-07
PMN K092287 | MNI Avalign Instruments & Implants	Armada Spinal System	2014-01-07
PMN K092287 | MNH Avalign Instruments & Implants	Armada Spinal System	2014-01-07
PMN K092287 | KWQ Avalign Instruments & Implants	Armada Spinal System	2014-01-07
PMN K092287 | KWP Avalign Instruments & Implants	Armada Spinal System	2014-01-07
PMN K083341 | KWQ Avalign Instruments & Implants	Helix T Anteriror Cervical Plating System	2014-01-07
PMN K081611 | ODP Avalign Instruments & Implants	Nuvasive CoRoent System	2014-01-07
PMN K073275 | KWQ Avalign Instruments & Implants	Helix Mini Anterior Cervical Plating System	2014-01-07
PMN K072339 | KWQ Avalign Instruments & Implants	Halo Anteriror Lumbar Plate System	2014-01-07
PMN K071329 | KWQ Avalign Instruments & Implants	Helix Anterior Cervical Plating System	2014-01-07
NBH Avalign Instruments & Implants	Arthroscopic Instruments	2014-01-07
PMN K120368 | MAX Avalign Instruments & Implants	Capstone Control Spinal System	2013-01-17
PMN K103404 | KWT Avalign Instruments & Implants	Anatomical Shoulder TM Combined System	2013-01-17
PMN K103404 | KWS Avalign Instruments & Implants	Anatomical Shoulder TM Combined System	2013-01-17
PMN K103404 | HSD Avalign Instruments & Implants	Anatomical Shoulder TM Combined System	2013-01-17
PMN K094042 | OVE Avalign Instruments & Implants	PEEK Prevail Cervical Interbody	2013-01-17
PMN K041452 | MQP Avalign Instruments & Implants	Vertestack Spinal System	2013-01-17
MDM Avalign Instruments & Implants	instrument	2013-01-17
HXX Avalign Instruments & Implants	4mm modular driver, flexible	2013-01-17
HXX Avalign Instruments & Implants	2.5mm modular retaining driver	2013-01-17
HXW Avalign Instruments & Implants	Bender	2013-01-17
HXP Avalign Instruments & Implants	Instrument	2013-01-17
HXD Avalign Instruments & Implants	Patella Reamer Clamp	2013-01-17
HXC Avalign Instruments & Implants	Wrench	2013-01-17
HXB Avalign Instruments & Implants	Probe	2013-01-17
HWX Avalign Instruments & Implants	Flexible Occipital Tap	2013-01-17
HWX Avalign Instruments & Implants	Bone Tap	2013-01-17
HWR Avalign Instruments & Implants	Driver, Prosthesis	2013-01-17
HWN Avalign Instruments & Implants	Compression Instrument	2013-01-17
HWK Avalign Instruments & Implants	Trephine	2013-01-17
HWJ Avalign Instruments & Implants	Awl	2013-01-17
HWB Avalign Instruments & Implants	Extractor	2013-01-17
HTW Avalign Instruments & Implants	Flexible Occipital Drill, 6MM	2013-01-17
HTW Avalign Instruments & Implants	Drill Bit	2013-01-17
HTR VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	rasp handle	2013-01-17
HTR VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Rasp 671150940, 671151040 671151140, 789351000, 789351100, 789351200, 789351300, 789351400, 789351500, 789351600	2013-01-17
HTR Avalign Instruments & Implants	rasp handle	2013-01-17
HTR Avalign Instruments & Implants	Rasp 671150940, 671151040 671151140, 789351000, 789351100, 789351200, 789351300, 789351400, 789351500, 789351600	2013-01-17
HTO Avalign Instruments & Implants	Pilot Drill	2013-01-17
HTJ Avalign Instruments & Implants	Depth Resection Gage	2013-01-17
HTF Avalign Instruments & Implants	Curette	2013-01-17
FZY Avalign Instruments & Implants	Slap Hammer	2013-01-17
FSM Avalign Instruments & Implants	Surgical Tray	2013-01-17
HWT VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Template	2011-07-18
HWT VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Rasp Alignement Tip Sz 10 thru 20	2011-07-18
HWT Avalign Instruments & Implants	Template	2011-07-18
HWT Avalign Instruments & Implants	Rasp Alignement Tip Sz 10 thru 20	2011-07-18
HWM Avalign Instruments & Implants	Osteotome	2011-07-18
GAD Avalign Instruments & Implants	Retractor	2011-07-18
GAD Avalign Instruments & Implants	ROMANELLI RETRACTOR	2011-07-18
LXH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	XIA III	2007-01-31
LXH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Reliance Lite	2007-01-31
LXH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	Orthopedic Manual Surgical	2007-01-31
LXH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	NEMCOMED ORTHOPEDIC	2007-01-31
LXH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	ES2 SPINAL SYSTEM	2007-01-31
LXH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	AVS ANCHOR-C CERVICAL CAGE SYSTEM	2007-01-31
LXH VIPER TECHNOLOGIES, LLC. [Avalign Instruments & Implants]	ARIA	2007-01-31
LXH Avalign Instruments & Implants	XIA III	2007-01-31
LXH Avalign Instruments & Implants	Reliance Lite	2007-01-31
LXH Avalign Instruments & Implants	Orthopedic Manual Surgical	2007-01-31
LXH Avalign Instruments & Implants	NEMCOMED ORTHOPEDIC	2007-01-31
LXH Avalign Instruments & Implants	ES2 SPINAL SYSTEM	2007-01-31
LXH Avalign Instruments & Implants	AVS ANCHOR-C CERVICAL CAGE SYSTEM	2007-01-31
LXH Avalign Instruments & Implants	ARIA	2007-01-31

Similar & Related FDA Registered Companies

• Avalign Nemcomed Instruments & Implants

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019100956075	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	STORAGE SYSTEMS HORIZONTAL LIFT HS-CODE 94032080	5 PKG