NuVasive Specialized Orthopedics, Inc.

FDA Device Registration & Listing · Audubon, PA, US · Registration 3006179046

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006179046
FEI Number
3006179046
Entity Name
NuVasive Specialized Orthopedics, Inc.
City/State/Country
Audubon, PA, US
Establishment Address
2560 General Armistead Ave, VALLEY FORGE BUSINESS CENTER, Audubon, PA 19403, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
NUVASIVE, INC. (Owner Number: 9036345)
Owner / Operator Contact Address
2560 General Armistead Ave, VALLEY FORGE BUSINESS CENTER, Audubon, PA 19403, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K161751
PMA Number
N/A

All Registered Proprietary Names

PRECICE UNYTE CoCr System IMPACTOR EXTRACTOR Screwdriver PRECICE intramedullary limb lengthening PRECICE intramedullary limb lengthening Precice Intramedullary Limb Lengthening System Precice Screws REAMER PRECICE Trauma Nail System Retractor Magec Spinal Bracing and Distraction system Precice® Bone Transport System PRECICE intramedullary limb lengthening Precice® Instrument Magec Spinal Bracing and Distraction System Precice® Instrument Precice® Plating System MAGEC® System PRECICE ERC 4P PRECICE UNYTE System PRECICE Intramedullary Limb Lengthening System PRECICE Trauma Nail System External Remote Controller ERC 4P Residual Limb Lengthening System Precice intramedullary limb lengthening PRECICE Trauma Nail System Template PRECICE IMLL Bone Transport PRECICE Intramedullary Limb Lengthening System Supplemental Instrument Trays MAGEC® System Mallet General Instruments DRIVER, PROSTHESIS Precice® Ankle Salvage System Precice Bone Transport PRECICE® STRYDE

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 2017-04-18
HWA Impactor Orthopedic Class 1 888.4540 2016-04-05
HWB Extractor Orthopedic Class 1 888.4540 2016-04-05
HXX Screwdriver Orthopedic Class 1 888.4540 2016-04-15
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2016-04-05
PGN Growing Rod System- Magnetic Actuation Orthopedic Class 2 888.3070 2016-11-17
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2016-04-05
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2023-03-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-03-20
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2020-05-26
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-05-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-05-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-05-26
HTO Reamer Orthopedic Class 1 888.4540 2016-04-05
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2016-04-05
GAD Retractor General, Plastic Surgery Class 1 878.4800 2016-04-15
PGN Growing Rod System- Magnetic Actuation Orthopedic Class 2 888.3070 2016-04-05
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-08-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-08-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2016-04-05
HTD Forceps General, Plastic Surgery Class 1 878.4800 2019-12-23
PGN Growing Rod System- Magnetic Actuation Orthopedic Class 2 888.3070 2016-04-05
HTE Elevator General, Plastic Surgery Class 1 878.4800 2019-12-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-12-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-12-23
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-12-23
PGN Growing Rod System- Magnetic Actuation Orthopedic Class 2 888.3070 2020-07-31
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-10-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-10-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2016-04-05
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-04-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-04-17
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2016-04-05
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-12-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-12-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-12-30
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2020-12-30
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2016-04-05
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2016-04-05
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2016-04-05
HWT Template Orthopedic Class 1 888.4800 2016-04-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-10-05
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-10-05
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2016-04-12
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2016-04-05
PGN Growing Rod System- Magnetic Actuation Orthopedic Class 2 888.3070 2017-09-08
HXL Mallet General, Plastic Surgery Class 1 878.4800 2016-04-15
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2006-11-02
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2016-04-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-10-15
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-10-15
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-06-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-06-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-04-04
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-04-04
PGN Growing Rod System- Magnetic Actuation Orthopedic Class 2 888.3070 2017-07-20

Official Correspondent

Daniel Paul

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NUVASIVE, 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
2031966 NUVASIVE, INC. SAN DIEGO, CA, US
3009144915 NUVASIVE, INC. Guaynabo, PR, 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
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2008 N/A 1
EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Similar Registrations

Registration Number Establishment Name Location
3018182995 LOLL FEINMECHANIK GMBH Tornesch Schleswig-Holstein, DE
3008599979 THE ORTHOPAEDIC IMPLANT COMPANY Reno, NV, US
3006783837 STRUCTURE MEDICAL, LLC. Naples, FL, US
3009732568 BGS BETA-GAMMA-SERVICE GMBH & CO KG Wiehl North Rhine-Westphalia, DE
1424263 Isomedix Operations, Inc. Libertyville, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006179046. Last updated year: 2026. Please use registration number 3006179046 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.