CD HORIZON® Spinal System 154213560
by Medtronic Sofamor Danek, Inc.
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00763000585365 | Date11 Sep 2022 | StatusListed |
Recalls
-
- Terminated Z-2603-2018
This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- CD HORIZON® Spinal System
- Generic Name
- Bone-screw internal spinal fixation system rod
- Model / Reference
- 154213560
- Primary DI / UDI-DI
- 00763000585365
- 510(k) Number
- FDA Product Code
- MNI, MNH, KWP, NKB, KWQ
- GMDN Term
- Bone-screw internal spinal fixation system rod
- Device Class
- Class II
- Regulation Number
- 888.3070, 888.3050, 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Medtronic Sofamor Danek, Inc.
Properties
Other properties (10)
- 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