Novel Spinal Spacer System 64351-246
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00844856012004 | Date31 Aug 2015 | StatusListed |
Recalls
-
- Terminated Z-0190-2010
Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Novel Spinal Spacer System
- Generic Name
- Polymeric spinal interbody fusion cage
- Model / Reference
- 64351-246
- Primary DI / UDI-DI
- 00844856012004
- 510(k) Number
- FDA Product Code
- MQP, MAX
- GMDN Term
- Polymeric spinal interbody fusion cage
- Device Class
- Class II
- Regulation Number
- 888.3060, 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
- Size
- Angle — 8 degreeWidth — 16 MillimeterLength — 26 MillimeterHeight — 46 Millimeter
Other devices from Alphatec Spine, Inc.
Properties
Other properties (10)
- Sterile: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No