VERTEX® Reconstruction System X1211128
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 | Number00643169114654 | Date21 Jul 2015 | StatusListed |
Recalls
-
- Terminated Z-1826-2016
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- VERTEX® Reconstruction System
- Generic Name
- Spinal bone screw, non-bioabsorbable
- Model / Reference
- X1211128
- Primary DI / UDI-DI
- 00643169114654
- 510(k) Number
- FDA Product Code
- KWP
- GMDN Term
- Spinal bone screw, non-bioabsorbable
- Device Class
- Class II
- Regulation Number
- 888.3050
- 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