Tranquil-C™ 522286
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB6785222860 | Date17 Dec 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181483 | Date27 Aug 2018 | StatusActive |
Official records
- FDA 510(k) database K181483
- FDA 510(k) database K170297
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tranquil-C™
- Generic name
- Metallic spinal interbody fusion cage
- Model / reference
- 522286
- Primary DI / UDI-DI
- B6785222860
- FDA product code
- MAX
- GMDN term
- Metallic spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Size
- Width — 18 MillimeterLength — 14 MillimeterHeight — 10 Millimeter
Other devices from Nexus Spine, L.L.C.
Properties
Other properties (10)
- Sterilise before use: 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