CD HORIZON® Spinal System X06123238
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 | Number00643169243965 | Date19 Jun 2015 | 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- Withdrawn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
- Spinal bone screw, non-bioabsorbable
- Model / Reference
- X06123238
- Primary DI / UDI-DI
- 00643169243965
- 510(k) Number
- FDA Product Code
- KWQ, MNI, NKB, MNH, OSH, KWP
- GMDN Term
- Spinal bone screw, non-bioabsorbable
- Device Class
- Class II
- Regulation Number
- 888.3060, 888.3070, 888.3050
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
- Size
- Length — 50.0 Millimeter
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