Fortex Pedicle Screw System C010-0092
by Xtant Medical Holdings, Inc.
Listed
Valid until
Not applicable
FDA recalls
1 ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM697C01000921 | Date16 Jan 2023 | StatusListed |
Recalls
-
- Ongoing Z-1773-2026
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Fortex Pedicle Screw System
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile
- Model / Reference
- C010-0092
- Primary DI / UDI-DI
- M697C01000921
- 510(k) Number
- FDA Product Code
- MNI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile
- Device Class
- Class II
- Regulation Number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Xtant Medical Holdings, Inc.
Properties
Other properties (12)
- Sterile: No
- Single Use: 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
- Manufacturing Date: No