Reef TA TA1-128140
by SeaSpine Orthopedics Corporation
Reef TA TA1-128140 is a Class II device made by SeaSpine Orthopedics Corporation, cleared under FDA 510(k) K192132 on 3 Dec 2019 and listed in FDA GUDID since 7 May 2020 (UDI-DI 10889981192464), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10889981192464 | Date7 May 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192132 | Date3 Dec 2019 | StatusActive |
Official records
- AccessGUDID record 10889981192464
- FDA 510(k) database K192132
Across registries
- FDA 510(k) K192132 decided 3 Dec 2019 Active
- FDA GUDID UDI-DI 10889981192464 listed 7 May 2020 Listed
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.
Timeline
- Cleared FDA 510(k) K192132
- Listed FDA GUDID 10889981192464
- Recall initiated FDA recalls Z-2554-2025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Reef TA
- Generic name
- Metal-polymer composite spinal interbody fusion cage
- Model / Ref / Catalog
- TA1-128140
- Primary DI / UDI-DI
- 10889981192464
- 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
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