Zero-P VA 04.647.119S
by Synthes
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Overview
The Zero-P VA implant is a non-synthetic, porous polymeric spinal interbody fusion cage designed for partial or total vertebral body removal surgery to facilitate bone fusion. This device provides mechanical stability and sufficient space for therapeutic spinal bone fusion, often combined with bone graft. Developed by Synthes GmbH, the Zero-P VA has received updates and improvements since its initial publication.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10705034750675 | Date14 Sep 2015 | StatusListed |
Recalls
-
- Terminated Z-0455-2014
A potential non conformance was identified with the Zero-P VA plate where the screw could back out if the blocking mechanism is not visually confirmed to properly cover the head of the screw.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Zero-P VA
- Generic Name
- Polymeric spinal interbody fusion cage
- Model / Ref / Catalog
- 04.647.119S, 04647119S
- Primary DI / UDI-DI
- 10705034750675
- 510(k) Number
- FDA Product Code
- OVE
- GMDN Term
- Polymeric spinal interbody fusion cage
- Device Class
- Class II
- Regulation Number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
Other devices from Synthes
Properties
Other properties (8)
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No