Novel 64735-026
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00844856017146 | Date31 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK050553 | Date18 Apr 2005 | StatusActive |
Recalls
-
- Terminated Z-0508-2009
Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot numbers: Part Number 64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Novel
- Generic name
- Vertebral body prosthesis
- Model / reference
- 64735-026
- Primary DI / UDI-DI
- 00844856017146
- 510(k) Number
- FDA product code
- MQP
- GMDN term
- Vertebral body prosthesis
- Device class
- Class II
- Regulation number
- 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Length — 17 MillimeterHeight — 26 MillimeterWidth — 15 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