CoRoent 6791513
CoRoent 6791513 is a Class II device made by NuVasive, LLC, cleared under FDA 510(k) K231735 on 11 Jul 2023 (5 earlier submissions) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00887517341198), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231735 | Date11 Jul 2023 | StatusActive |
| United States | GUDID listing | Number00887517341198 | Date24 Oct 2015 | StatusListed |
Official records
- AccessGUDID record 00887517341198
- FDA 510(k) database K231735
- FDA 510(k) database K192582
- FDA 510(k) database K170961
- FDA 510(k) database K161442
- FDA 510(k) database K142299
- FDA 510(k) database K102547
Across registries
- FDA 510(k) K231735 decided 11 Jul 2023 Active
- FDA GUDID UDI-DI 00887517341198 listed 24 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K102547
- Cleared FDA 510(k) K142299
- Listed FDA GUDID 00887517341198
- Cleared FDA 510(k) K161442
- Cleared FDA 510(k) K170961
- Cleared FDA 510(k) K192582
- Cleared FDA 510(k) K231735
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CoRoent
- Generic name
- Spinal bone screw, non-bioabsorbable
- Model / reference
- 6791513
- Primary DI / UDI-DI
- 00887517341198
- FDA product code
- ODP, OVE
- GMDN term
- Spinal bone screw, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Spinal bone screw, non-bioabsorbable.
- AccelFix Spinal Fixation System (Sterile) 8102-6540S by L&K Biomed
- KHEIRON 28IW15065 by S.M.A.I.O
- Mecta-C Cervical Plate System 03.70.069 by Medacta International SA
- AccelFix Spinal Fixation System (Sterile) 8103-6550S by L&K Biomed
- AEGIS 187155032 by Depuy Spine, Inc.
- GSST-0702-2008-CE(4) by GS Medical Co., Ltd.
- Titanium Rod(NS2) T04715100 by Tianjin Zhengtian Medical Instrument Co., Ltd.
- Sterile Posterior Spinal Fixation System SR-C221-55080 by Shanghai Reach Medical Instrument Co., Ltd
- KHEIRON 26TC20075 by S.M.A.I.O
- RIALTO™ SI FUSION SYSTEM 74200001255 by MEDTRONIC SOFAMOR DANEK, INC.