CoRoent 5134320
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231735 | Date11 Jul 2023 | StatusActive |
| United States | GUDID listing | Number00887517577481 | Date24 Oct 2015 | StatusListed |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CoRoent
- Generic name
- Metallic spinal interbody fusion cage
- Model / reference
- 5134320
- Primary DI / UDI-DI
- 00887517577481
- FDA product code
- MQP, MAX, ODP, PHM, OVE
- GMDN term
- Metallic spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3060, 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Other devices from NuVasive, LLC
Properties
Other properties (11)
- Supplied sterile: No
- Single 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