FDA Registration
Active
🇺🇸 United States
NuVasive Specialized Orthopedics, Inc.
Reg #: 3006179046
·
FEI: 3006179046
·
Expires 2026
Products
23
Proprietary Names
44
Establishment Types
2
Classifications
23
Registration Details
- Registration Name
- NuVasive Specialized Orthopedics, Inc.
- Registration Number
- 3006179046
- FEI Number
- 3006179046
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2560 General Armistead Ave, VALLEY FORGE BUSINESS CENTER
- City
- Audubon
- State
- PA
- ZIP
- 19403
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162927
Owner / Operator
- Firm Name
- NUVASIVE, INC.
- Operator Number
- 9036345
- Address
- 2560 General Armistead Ave, VALLEY FORGE BUSINESS CENTER
- City
- Audubon
- State
- PA
- Postal Code
- 19403
- Country
- US
- Correspondent
- Daniel S Paul
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2017-04-18 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2016-04-05 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2016-04-05 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2016-04-15 |
| Growing Rod System- Magnetic Actuation | PGN | Class 2 | Orthopedic | No | 2016-11-17 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-03-20 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2020-05-26 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-05-26 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2016-04-05 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2016-04-15 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2019-12-23 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2019-12-23 |
| Template | HWT | Class 1 | Orthopedic | No | 2016-04-15 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2016-04-05 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2016-04-15 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-11-02 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2016-04-05 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2016-04-15 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2016-04-05 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2016-04-15 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2016-04-15 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2016-04-05 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2016-04-15 |
Proprietary Names
PRECICE UNYTE CoCr System
IMPACTOR
EXTRACTOR
Screwdriver
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® Instrument
Magec Spinal Bracing and Distraction System
Precice® Plating System
MAGEC® System
PRECICE ERC 4P
PRECICE UNYTE System
PRECICE Intramedullary Limb Lengthening System
External Remote Controller ERC 4P
Residual Limb Lengthening System
Precice intramedullary limb lengthening
Template
PRECICE IMLL Bone Transport
Supplemental Instrument Trays
Mallet
General Instruments
DRIVER, PROSTHESIS
Precice® Ankle Salvage System
Precice Bone Transport
PRECICE® STRYDE
ERC 3P
Awl
BIT, DRILL
Precice Ankle Salvage System
Wrench
PRECICE® Bone Transport System
PRECICE Bone Transport System
Tape, Measuring, Rulers and Calipers
Magec 2 Spinal Bracing and Distraction system
GAUGE, DEPTH
PRECICE UNYTE Bone Transport
Instrument, Compression
MAGEC Spinal Bracing and Distraction System
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only