Mariner Cap 569326
by SeaSpine Orthopedics Corporation
Mariner Cap 569326 is a Class II device made by SeaSpine Orthopedics Corporation, cleared under FDA 510(k) K201240 on 5 Aug 2020 and listed in FDA GUDID since 24 Nov 2020 (UDI-DI 10889981220945), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10889981220945 | Date24 Nov 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201240 | Date5 Aug 2020 | StatusActive |
Official records
- AccessGUDID record 10889981220945
- FDA 510(k) database K201240
Across registries
- FDA 510(k) K201240 decided 5 Aug 2020 Active
- FDA GUDID UDI-DI 10889981220945 listed 24 Nov 2020 Listed
Timeline
- Cleared FDA 510(k) K201240
- Listed FDA GUDID 10889981220945
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mariner Cap
- Generic name
- Internal spinal fixation system cable tensioner
- Model / Ref / Catalog
- 569326
- Primary DI / UDI-DI
- 10889981220945
- 510(k) Number
- FDA product code
- OWI
- GMDN term
- Internal spinal fixation system cable tensioner
- Device class
- Class II
- Regulation number
- 888.3010
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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