Reef TA TA1-928105
by SeaSpine Orthopedics Corporation
Listed
Valid until
Not applicable
FDA recalls
1 ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10889981194000 | Date7 May 2020 | StatusListed |
Recalls
-
- Ongoing Z-2554-2025
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Reef TA
- Generic Name
- Metal-polymer composite spinal interbody fusion cage
- Model / Ref / Catalog
- TA1-928105
- Primary DI / UDI-DI
- 10889981194000
- FDA Product Code
- MAX
- GMDN Term
- Metal-polymer composite spinal interbody fusion cage
- Device Class
- Class II
- Regulation Number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
Other devices from SeaSpine Orthopedics Corporation
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