CorticaLINK 80-4002/035
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817329020035 | Date30 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160722 | Date7 Jul 2016 | StatusActive |
Official records
- AccessGUDID record 00817329020035
- FDA 510(k) database K160722
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- Withdrawn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
- CorticaLINK
- Generic name
- Bone-screw internal spinal fixation system, non-sterile
- Model / Ref / Catalog
- 80-4002/035
- Primary DI / UDI-DI
- 00817329020035
- 510(k) Number
- FDA product code
- MNH, MNI, NKB
- GMDN term
- Bone-screw internal spinal fixation system, non-sterile
- Device class
- Class II
- Regulation number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Outer Diameter — 5.0 MillimeterLength — 35 Millimeter
Other devices from Linkspine, Inc.
Properties
Other properties (10)
- Supplied sterile: No
- Implantable: 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