FDA Registration
Active
🇺🇸 United States
ISOLA Spine System Rod Cutter
Reg #: 1526439
·
FEI: 1526439
·
Expires 2025
Products
1
Proprietary Names
23
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DEPUY SPINE, INC.
- Registration Number
- 1526439
- FEI Number
- 1526439
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 325 Paramount Drive
- City
- RAYNHAM
- State
- MA
- ZIP
- 02767
- Country
- US
Owner / Operator
- Firm Name
- DePuy Spine, Inc.
- Operator Number
- 1526439
- Address
- 325 Paramount Drive
- City
- Raynham
- State
- MA
- Postal Code
- 02767
- Country
- US
- Correspondent
- Karen Parker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2014-04-28 |
Proprietary Names
ISOLA Spine System Rod Cutter
Expedium Spine System Bender, Forceps, Cutter, Pan, Alignment Fork, Quick Stick Frame, Modular Clamp or Tap
Expedium Anterior Spine System Driver, Case, Caddy, Lid, Tray or Rod Reducer
ISOLA Spine System Holder
TLIF SG Instruments Vertebral Spreader
Expedium Spine System Inserter, Probe, Handle, Tap, SI Clip-On Reduction Device Clip Assembly with Pins, Driver orSleeve
Expedium Spine System Guide, DI Reduction Tube for Clip-on, Rod Stabilizer, Pedicle Screw Sizer or Pedicle Finder
Moss Miami Magnum Spine System Feeler
Moss Miami Spine System Clamp, Compressor, Distractor, or Remover
Viper System Screw Extension, Closed, Tray, Case, Caddy, Lid, Driver, Screwdriver, Tap, Wrench, Tightener or Shaft
Monarch Spine System Distractor, Clamp, Compressor, Rocker, Holder, Rod-template or Pusher
Expedium Spine System Tab Key, Tab remover, Lamina/Transverse Process Starter, Elevator, Rongeur or Gage
Expedium SFX Cross Connector System Case, Tray, Lid, Caddy, Name Plate, Handle, Label, Inserter, Shaft or Plate Ruler
Viper System Post, Tap, Handle or Cap
Expedium Spine System Case, Caddy, Lid, Tray, Laminar Finder, Thoracic Facet Finder, Shaft, Sleeve, Tap or Guide
Expedium Spine System Wire Cutter
Expedium SFX Cross Connector System Stabilizer or Bender
Moss Miami Spine System Pusher
Expedium Spine System Feeler, Wire Cutter, Compressor, Distractor or Pusher
Expedium Spine System Stabilizer, Tab Key, Tab remover, Reduction Clip, Pedicle Finder, Hook Starter or Rotator
Expedium Spine System Rod Approximator, Flex. Clipon Reduction device clip, Facilitator or DI Clip-On Reduction Device
Monarch Spine System Probe, Handle, Bender, Driver, Screwdriver, Rod Template or Wrench
Expedium Powered Instruments, ELLIPTICAL HANDLE, T-HANDLE, RATCHETING
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility