Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006128100

FEI Number

3006128100

Entity Name

Nemcomed FW LLC

City/State/Country

FORT WAYNE, IN, US

Establishment Address

8727 Clinton Park Drive, 8414 Clinton Park Drive, FORT WAYNE, IN 46825, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Avalign Instruments & Implants (Owner Number: 9008280)

Owner / Operator Contact Address

8727 Clinton Park Drive, --, Fort Wayne, IN 46825, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PEEK Prevail Cervical Interbody Medtronic IPC Powerease System 234850714 DISTAL SM MEDIAL HUM PLT 14 H 234850712 DISTAL SM MEDIAL HUM PLT 12 H 234850716 DISTAL SM MEDIAL HUM PLT 16 H Awl PROX TARGETING GUIDE HUMERAL 225550400 MDN OBLIQUE HOLE ADAPTOR HUM 225550401 PROX TARGETING GDE TIBIAL 225550300 Slap Hammer FLEXIBLE DRILL SCREW II SHAFT MODULAR Inbone Combo Wrench 12MM/16MM Inbone Extraction Wrench Inbone Combo Wrench 14MM/18MM Wrench 235852705 RADIAL STYLOID LOCKING PLATE 5H RT 235852703 21DIAL STYLOID LOCKING PLATE 3H RT 235852805 RADIAL STYLOID LOCKING PLATE 5H LT 235852803 RADIAL STYLOID LOCKING PLATE 3H LT Orthopedic Manual Surgical ES2 SPINAL SYSTEM Reliance Lite AVS ANCHOR-C CERVICAL CAGE SYSTEM XIA III ARIA NEMCOMED ORTHOPEDIC Prophecy Adapter 16MM Insert Prophecy Adapter 18MM Insert Prophecy C-Bracket Adapter Prophecy Adapter Screw Adjust SMALL CM FLEX CAPT SET SC 00249003506 STD CM FLEX CAPT SET SCREWDRIVER 00249003507 Vertestack Spinal System Medtronic Catalyft LS Expandable Interbody System DePuy 2.4/3.2/4 Rasp 671150940, 671151040 671151140, 789351000, 789351100, 789351200, 789351300, 789351400, 789351500, 789351600 rasp handle Stimulation instrument Cannula, Surgical, General & Plastic Surgery Arthroscopic Instruments Extractor OsteoCentric APFT Wires and Drill Sleeves Mallet Zimmer Affixus Medtronic Drills, Burrs, Trephines & Accessories Alphatec ALIF SA Medtronic CD Horizon Spinal System DePuy Expedium Verse Navigation Driver - Shaft 2.5mm modular retaining driver 4mm modular driver, flexible Silony - T10 Straight Screwdriver, Modular Medtronic K141599 Flexible Occipital Drill, 6MM Drill Bit NuVasive NVJJB System ZMR Hip System instrument Driver, Prosthesis Pilot Drill Inbone Drive LH Reamer Flexible Occipital Tap Bone Tap 234753500 REG LAT CALCANEAL PLT RT 234753600 REG LAT CALCANEAL PLT LT 301021107 - 301021115 Template Rasp Alignement Tip Sz 10 thru 20 DePuy Synthes NAV Drill Guide Assembly Depth Resection Gage Anatomical Shoulder TM Combined System Retractor ROMANELLI RETRACTOR Patella Reamer Clamp Trephine

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTX	Rongeur	Orthopedic	Class 1	888.4540	2013-01-21
HTX	Rongeur	Orthopedic	Class 1	888.4540	2013-01-21
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-09-10
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2013-01-17
LRN	Wire, Surgical	Orthopedic	Class 2	888.3030	2023-04-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-11-01
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2022-11-01
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-27
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2026-01-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-05-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-05-28
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2024-05-28
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2024-05-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-05-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2024-05-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2024-05-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-28
HWJ	Awl	Orthopedic	Class 1	888.4540	2013-01-17
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-26
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-11-28
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-01-28
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2013-01-28
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2013-01-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-26
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2026-01-27
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-17
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2013-01-21
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2015-09-23
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-01-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-11-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-28
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2026-01-26
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-26
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-21
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-01-17
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-01-31
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-01-07
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-11-28
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-21
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2021-12-27
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2021-02-07
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-17
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-01-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-11-12
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-27
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-11-02
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-09-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-09-19
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-09-19
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2013-01-28
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-01-28
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2013-01-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
HWW	Countersink	Orthopedic	Class 1	888.4540	2023-09-10
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-01-17
NTG	Prosthesis, Ankle, Uncemented, Non-Constrained	Unknown	Class 3	N/A	2016-01-29
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2014-01-07
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-04-13
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2014-01-07
HWB	Extractor	Orthopedic	Class 1	888.4540	2013-01-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-21
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2026-01-27
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-01-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-26
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2018-08-13
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2017-04-13
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-09-30
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2026-01-27
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-01-07
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2026-01-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-02-16
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-04-13
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-04-13
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-27
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2024-06-06
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2026-01-27
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2026-01-26
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2026-01-26
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2013-01-21
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-21
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2026-01-27
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-01-28
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2026-01-27
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2024-03-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-03-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-03-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2024-03-18
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2024-03-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2024-03-18
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2026-01-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-01-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-26
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-06-06
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-01-17
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-06-01
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2026-01-27
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-01-25
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	2026-01-26
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2014-01-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2014-01-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-01-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-01-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-01-07
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2026-01-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-05-12
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-01-31
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2013-01-31
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2013-01-31
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2013-01-31
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2013-01-31
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2013-01-31
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-01-31
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-01-31
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-01-31
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-26
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2025-11-25
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2026-01-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-26
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2026-01-26
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-21
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-05-25
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-01-17
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2014-01-07
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2014-01-07
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2014-01-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-08-13
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2019-08-13
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2019-08-13
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2019-08-13
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-08-13
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-05-23
KTZ	Caliper	Orthopedic	Class 1	888.4150	2013-01-25
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2014-01-07
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2026-01-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-26
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-26
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2023-09-10
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-01-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-26
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-01-07
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2014-01-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2014-01-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2014-01-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-01-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-01-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-27
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2013-01-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-03-05
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2013-01-17
HTO	Reamer	Orthopedic	Class 1	888.4540	2013-01-17
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-01-17
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2015-06-01
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-27
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-01-07
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-06-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
HWT	Template	Orthopedic	Class 1	888.4800	2011-07-18
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-09-10
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2023-09-10
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2026-01-27
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2023-09-10
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-01-07
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-07-08
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2023-09-21
HXG	Tamp	Orthopedic	Class 1	888.4540	2013-01-21
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2013-01-17
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-01-17
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-01-17
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2013-01-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2026-01-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-21
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2011-07-18
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2026-01-26
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-05-17
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2013-01-17
HWK	Trephine	Orthopedic	Class 1	888.4540	2013-01-17

Official Correspondent

Jeff Robinson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Avalign Instruments & Implants

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013413393	Avalign Additive / Slice Manufacturing Studios	Akron, OH, US
3026776	VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)	Parkrose, OR, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

Similar Registrations

Registration Number	Establishment Name	Location
3043008835	STARK SURGICAL INSTRUMENTS	Moorpark, CA, US
1226544	MILLSTONE MEDICAL OUTSOURCING LLC.	FALL RIVER, MA, US
3011577940	Titan Spine, a Division of Medtronic	Milwaukee, WI, US
3007648354	FETZER MEDICAL GMBH & CO.KG	Tuttlingen Baden-Wurttemberg, DE
3006846753	Bradshaw Medical Inc.	Kenosha, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006128100. Last updated year: 2026. Please use registration number 3006128100 when referencing this establishment in official correspondence.