Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004464325

FEI Number

3004464325

Entity Name

DEPUY ORTHOPAEDICS

City/State/Country

BRIDGEWATER, MA, US

Establishment Address

50 SCOTLAND BLVD., BRIDGEWATER, MA 02324, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

DePuy Synthes, Inc. (Owner Number: 1818910)

Owner / Operator Contact Address

700 Orthopaedic Drive, Warsaw, IN 46582, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM Spine Bale SYNTHES USS, CLICK`X, USS VAS, DUAL Rongeur for Joint Recon Expedium TELIGEN SYNTHES SYNMESH SPACER SYSTEM Synthes Cortex Screws Mitek GRAFT KNIVES Mountaineer MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) bur Pulse Lumbar Screw Implants drill kit Mitek ARTHROSCOPIC SURGERY INSTRUMENT SyntheCel Joing Recon Forceps, Wire Holding mountaineer Expedium Viper dissector, surgical, general & plastic surgery Dental Bone Cutting Instruments Expedium Spine System USS-LINE EXTENSION SYNTHES SPINE OCCIPITAL-CERVICAL PL SYNTHES (USA) [SYNTHES] MINI EXTERN Spine Ti SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM Bone Punch, Tibial Punch, Femoral Punch, Acetabular Punch Charnley Punch, Surgical Hammertoe Continuous Compression Implant Rasp for Joint Recon RASP Mitek EYED NEEDLE SYNTHES (USA) TIBIAL NAIL SYSTEM EX Impactor Instruments (Joint Recon) Bengal Expedium Viper Concorde Devex RAM Wire Cable (joints) LOW PROFILE HALO VEST ASSEMBLY traction ORTHOPAEDIC TRACTION ACCESSORY ACE MARKIII ASSEMBLY Akros Fibulink Syndesmosis Repair Kit Joint Recon Cutting Instrument TELIGEN bit screw ADJUSTABLE LARGE FIXATOR SYSTEM Sentio MMG Gen2 Bengal SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP Depuy Synthes Retrograde Femoral Nail Advanced System and DePuy Synthes Locking Screws for Medullary Nails, 5 mm CONCORDE Clear MIS Discectomy Device SYNTHES VECTRA SYSTEM SYNTHES ANTERIOR TENSION BAND (ATB) Orthopaedic EXTRACTOR ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - ATTUNE SLEEVE WEDGE ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - BASE ATTACHMENT ATTUNE REVISION TIBIAL BASE TRIAL EXTRACTOR ATTUNE REVISION BOSS AND STEM ADAPTOR TRIAL EXTRACTOR PINNACLE Dual Mobility TELIGEN Spine Mesh DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) Spine Halo Charnley Mitek ELEVATOR SYNTHES (USA) 2.4/2.7 MM LOCKING FO Instrument Retractors TELIGEN SYNEX II Mitek CANNULA SYNTHES MATRIX MIS RODS Spotlight bone filler SYNTHES (USA) CLAVICLE HOOK PLATES Devex Spine Port Spotlight Rhythmlink International Subdermal Needle Electrodes SYNTHES ANTERIOR CSLP SYSTEM chisel, instrument guide, hammer, mallet, osteotome, rasp, retractor, saw, calipers TELIGEN Kaneda Sr Porous Polyethylene Implants Joint Recon Hammers VARIOUS TYPES OF HAMMERS Strickland TELIGEN SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM DOC Ventral Cervical Stabilization System Joint Recon Bone Hook Instrument DePuy Synthes 2mm Quick Insertion Screws Tandem Connector Concorde Curve Spinal System Viper System E-Z X System Pulse Anterior Cervical Plate System Implants compression instrument for Joint Recon Viper Prime ARICULATED TENSION DEVICE SYNTHES TEN Mountaineer Expedium USS Iliosacral and Polyaxial System Synthes SyntheCel Dura Replacement Devices DePuy Synthes VOLT Mini Fragment Plating System and VOLT Small Fragment Plating System DePuy Synthes 4 Mm And 4.5 Mm Cortex Screws, DePuy Synthes 2.4 Mm Cannulated Screws, DePuy Synthes 3.5 Mm And 4 Mm C SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM SYNTHES USS (10MM SIDE OPENING SCREWS SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM Mitek KNOT PUSHER tape, measuring, rulers and calipers for Joint Recon measuring Viper Prime Uniplate PULSE Cervical Cage System Implants scissors Surgical Scissors Accessories/Attachmnts to AC Powered Motors for Joint Recon SYNTHES CERVIFIX SYSTEM Sentio MMG NeuralMAS Symphony Synthes Navigable Pedicle Preparation Instruments Joint Recon Surgical instrument motors and accessories/attachments Sentio MMG Joint Ortho Tamp Instrument CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP Introduction/drainage catheter and accessories Titanium Screws instrument tray, instrument case Viper Prime ATTUNE REVISION SOLID RP INSERTS SIZE 5-6 CASE ATTUNE REVISION SOLID RP INSERTS SIZE 3-4 CASE ATTUNE REVISION TIBIAL BROACH CADDY ATTUNE REVISION SOLID RP INSERTS SIZE 7-8 CASE PINNACLE Dual Mobility viper monarch expedium Bengal Spine Monoaxial Screw SYNTHES (USA) EXTERNAL MULTI VECTOR Orthopaedic TAP Viper Pulse Lumbar Cage Implants SYNAPSE SYSTEM broach, wire cutter, prosthesis driver, extractor, file, femoral neck punch, reamer, screwdriver, tamp wrench, etc. Attune Pinnacle Viper Prime ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 5 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 4 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 8 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 3 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 7 ATTUNE REVISION FEMORAL IM ADAPTOR ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 6 PINNACLE Dual Mobility TELIGEN SYNTHES VECTRA-T SYSTEM Expedium SYNTHES SPINE UNIVERSAL SPINAL HOOK 6.5mm Midfoot Fusion Bolt TORQUE LIMITING ATTACHMENT SYNTHES (USA) REAMER IRRIGATOR AS Radial Head DePuy Synthes 3.5 mm Intrapelvic Acetabular System SYNTHES LARGE FRAGMENT DYNAMIC COMP Expedium SYNTHES DUAL-OPENING USS SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM SYNTHES (USA) COMPACT AIR DRIVE II Kaneda Sr SMALL STATURE USS Mountaineer orthopaedic knife Mitek KNIFE BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL blade Caliper Instruments (Joint Recon) Viper Prime Bengal SYNTHES MEDIUM EXTERNAL FIXATION SY Synthes 90 Degree Screwdriver SYNTHES MODULAR FOOT SYSTEM Bone Marrow Aspiration (BMA) Syringe Sentio MMG retractor SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM SYNTHES STERILE DRILL BITS Mitek SUTURE CUTTER SYNTHES ANTERIOR CERVICAL LOCKING P Joint Recon instrument -chisel, surgical, manual Expedium spine instrument battery Concorde Bullet Isola Trephine Spine Washer filler SYNTHES (USA) SMALL ADJUSTABLE CLAM various broach instruments ATTUNE REVISION TIBIAL BROACH 45MM ATTUNE REVISION TIBIAL BROACH 61MM ATTUNE REVISION TIBIAL BROACH 37MM ATTUNE REVISION TIBIAL BROACH 29MM ATTUNE REVISION TIBIAL BROACH 53MM ATTUNE REVISION TIBIAL BROACH 69MM VIPER PRIME SYNTHES CERVIFIX/ AXON SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SY Proxima TELIGEN Mitek PROBE templates guides instrument SYNTHES VECTRA-ONE SYSTEM SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS) CLAMPFIX Screwdrivers for Joint Recon Viper Prime SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM Joint Recon Curettes TELIGEN Clamp for Joint Recon Burr, Orthopedic various osteotome general instruments TELIGEN various prosthesis drivers ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - DRIVER TELIGEN COUNTERSINK (MULTIPLE BRANDS) SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM SYNTHES (USA) RIA SYSTEM Orthomesh VAPR surgical instrument motor power Spine Halo Viper 3.5mm Locking Attachment Plates SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL Synthes Clampfix System Synthes 2.7mm and 3.5mm Variable Angle LCP Midfoot/Hindfoot System Lere Akros Fibulink Syndesmosis Repair Kit ChronOS BMA SYNTHES AIR PEN DRIVE (APD) SYSTEM Skyline Anterior Cervical Plate System Orthopaedic REAMER ATTUNE REVISION RP CONICAL REAMER osteotome, manual

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-08-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-01-16
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-08-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-08-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-08-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-08-17
HTX	Rongeur	Orthopedic	Class 1	888.4540	1979-06-26
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2023-08-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-17
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	1980-12-01
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2016-11-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-11-17
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2023-08-17
OXB	Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction	General, Plastic Surgery	Class 2	878.3300	2023-08-17
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2023-08-17
OXE	Mesh, Surgical, Collagen, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2023-08-17
PAJ	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2023-08-17
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2023-08-17
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2023-08-21
HTO	Reamer	Orthopedic	Class 1	888.4540	2023-05-17
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-05-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-12-07
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2023-12-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-10-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-10-31
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-10-31
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-10-31
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-10-31
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-08-21
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2012-12-14
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2023-08-17
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	1979-06-26
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2023-05-17
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	1979-06-26
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	1980-11-24
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2023-08-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-10-31
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-10-31
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-10-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-10-31
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-10-31
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-08-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-08-17
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-08-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-08-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-08-17
JEY	Plate, Bone	Dental	Class 2	872.4760	2023-08-17
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2025-06-13
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-01-16
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2017-01-16
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2017-01-16
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2023-08-17
JEY	Plate, Bone	Dental	Class 2	872.4760	2023-08-17
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	1993-11-26
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-17
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	1984-03-09
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2012-12-08
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-16
HWA	Impactor	Orthopedic	Class 1	888.4540	1993-01-04
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2016-11-30
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	1993-01-04
LRN	Wire, Surgical	Orthopedic	Class 2	888.3030	2015-06-30
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	1978-03-27
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2023-07-07
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	1979-06-26
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2023-12-15
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	1978-03-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-17
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2023-08-17
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2018-06-13
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2018-06-13
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2017-01-16
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-01-16
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-01-16
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2023-08-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-17
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-08-17
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2018-08-17
MQN	External Mandibular Fixator And/Or Distractor	Dental	Class 2	872.4760	2023-05-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-08-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-08-17
HWB	Extractor	Orthopedic	Class 1	888.4540	1979-06-26
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	1997-11-12
EZX	Mesh, Surgical, Metal	General, Plastic Surgery	Class 2	878.3300	2016-11-30
HBW	Fastener, Plate, Cranioplasty	Neurology	Class 2	882.5360	2023-08-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-01-16
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1981-02-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-17
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1992-10-16
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2023-08-16
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1984-03-09
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-08-16
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-08-16
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-08-16
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-08-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-08-16
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1981-02-23
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2023-08-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-17
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-06-15
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2017-01-16
FSQ	Light, Surgical, Instrument	General, Plastic Surgery	Class 2	878.4580	2016-10-31
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2016-10-31
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2023-08-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-08-17
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2001-08-11
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2023-12-15
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-09-08
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2023-08-17
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-08-17
GWO	Plate, Cranioplasty, Preformed, Alterable	Neurology	Class 2	882.5320	2023-08-17
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	1981-03-02
JEB	Table, Surgical With Orthopedic Accessories, Manual	General, Plastic Surgery	Class 1	878.4950	2016-01-15
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2023-08-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-10-31
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2015-09-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-16
PGM	Growing Rod System	Orthopedic	Class 2	888.3070	2017-09-20
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2016-10-31
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-10-31
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2017-11-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-11-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-11-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-11-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2017-11-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2017-11-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-11-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2017-11-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-11-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-10-31
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2015-11-09
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1981-02-23
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-08-16
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-08-16
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-08-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-08-16
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-08-16
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2023-08-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-07-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-07-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-17
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2023-07-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-08-16
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-08-16
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-08-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-08-16
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-08-16
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2023-08-16
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	1981-02-23
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	1981-03-02
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-09-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-10-31
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2016-10-31
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	1994-03-22
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2007-12-13
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-08-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-08-17
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2018-04-10
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2016-10-31
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-08-16
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-08-16
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2001-08-21
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2018-06-12
HXG	Tamp	Orthopedic	Class 1	888.4540	1993-01-04
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2023-08-17
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2023-08-21
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2016-11-30
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1992-12-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-09-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-09-21
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2016-09-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-09-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-09-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-09-21
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2017-01-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-01-16
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2023-08-17
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2012-12-12
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-10-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-10-31
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-10-31
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-10-31
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-10-31
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-08-17
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-06-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-08-16
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	1984-03-09
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-08-16
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-08-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-16
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2023-08-21
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-08-17
HTO	Reamer	Orthopedic	Class 1	888.4540	2023-08-17
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2023-08-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-17
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2023-08-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-09-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-09-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-09-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-09-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-09-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-08-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-08-17
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-08-17
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-08-17
HTO	Reamer	Orthopedic	Class 1	888.4540	2023-08-17
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2023-08-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-09-08
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-08-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-08-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-08-17
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	1981-02-23
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	1977-12-22
KTZ	Caliper	Orthopedic	Class 1	888.4150	2015-11-06
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2023-08-17
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2023-08-16
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2023-08-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-08-17
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2018-04-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-10-29
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	1981-03-02
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-08-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-16
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2023-08-17
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2023-08-17
HSZ	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2023-08-17
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2023-08-17
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	1981-03-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-08-17
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1977-12-22
MOQ	Battery, Replacement, Rechargeable	General, Plastic Surgery	Class 1	878.4820	2023-08-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-01-16
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2017-01-16
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-01-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-09-08
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-09-08
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2017-09-08
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2017-09-08
HWK	Trephine	Orthopedic	Class 1	888.4540	1993-01-04
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2023-05-15
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2023-05-15
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2023-05-15
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2023-05-15
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-11-30
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-11-30
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-11-30
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2023-08-16
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2023-08-17
HTQ	Broach	Orthopedic	Class 1	888.4540	1993-01-04
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-08-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-08-17
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2023-05-17
JEY	Plate, Bone	Dental	Class 2	872.4760	2023-08-17
HXB	Probe	Orthopedic	Class 1	888.4540	1992-12-02
HWT	Template	Orthopedic	Class 1	888.4800	1992-11-22
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	1978-03-27
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-08-16
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2023-08-17
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-08-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-08-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-08-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-08-17
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-08-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-08-17
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2000-03-01
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-08-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-08-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-08-17
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	1992-10-16
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	1978-03-27
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	1981-03-02
JEY	Plate, Bone	Dental	Class 2	872.4760	2023-05-17
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2000-02-28
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	1993-01-04
HWW	Countersink	Orthopedic	Class 1	888.4540	2023-08-21
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-08-17
HTO	Reamer	Orthopedic	Class 1	888.4540	2023-08-17
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2023-08-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-17
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-11-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-11-09
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2001-08-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-01-16
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-11-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-11-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-11-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-11-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-08-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-08-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-08-17
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-08-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-08-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-17
LYS	Bone Mill	Orthopedic	Class 1	888.4540	1998-05-27
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2023-07-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-08-17
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2023-08-17
HBB	Motor, Drill, Pneumatic	Neurology	Class 2	882.4370	2023-08-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-10-31
HTO	Reamer	Orthopedic	Class 1	888.4540	1993-01-04
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2023-08-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DePuy Synthes, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009421413	GMED Healthcare BV (a Johnson & Johnson Company)	Leeds, GB
3004715683	Memphis Logistic Center	Memphis, TN, US
3015516266	Depuy Ireland UC	Co. Cork Munster, IE
1219655	DEPUY ORTHOPAEDICS, INC.	RAYNHAM, MA, US
1818910	DEPUY ORTHOPAEDICS, INC.	WARSAW, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004464325. Last updated year: 2026. Please use registration number 3004464325 when referencing this establishment in official correspondence.