Device product
VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.
Z-2258-2013
Product summary
- Event
- Event 65999
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32
- Official record key
device-enforcement:Z-2258-2013
Official wording
Reason: The product has the potential to be laser marked as a Medium when it actually is a Small.
Code information: Part Number: 0301-1410, Lot 53AR
Distribution pattern: Distributed in FL.
Derived failure modes
-
Unknown
The product has the potential to be laser marked as a Medium when it actually is a Small.