APEX Spine System 6000-090ML
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00193082004865 | Date25 Mar 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132603 | Date20 Nov 2013 | StatusActive |
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- Withdrawn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
- APEX Spine System
- Generic name
- Bone-screw internal spinal fixation system rod
- Model / Ref / Catalog
- 6000-090ML
- Primary DI / UDI-DI
- 00193082004865
- FDA product code
- KWQ, MNI, NKB, KWP, MNH
- GMDN term
- Bone-screw internal spinal fixation system rod
- Device class
- Class II
- Regulation number
- 888.3060, 888.3070, 888.3050
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Other devices from Spinecraft LLC
Properties
Other properties (10)
- Supplied sterile: 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