Novel 64105-112
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00844856008649 | Date31 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK080699 | Date21 May 2008 | StatusActive |
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- Withdrawn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 — FDA 510(k) Active
Specification
- Trade name
- Novel
- Generic name
- Vertebral body prosthesis
- Model / reference
- 64105-112
- Primary DI / UDI-DI
- 00844856008649
- 510(k) Number
- FDA product code
- MQP, MAX
- GMDN term
- Vertebral body prosthesis
- Device class
- Class II
- Regulation number
- 888.3060, 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Height — 12 MillimeterLength — 25 MillimeterWidth — 10 Millimeter
Other devices from Alphatec Spine, Inc.
Properties
Other properties (10)
- Supplied 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