Known Identifiers & Locations
FEI Numbers
2027467
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0036-2010 |
ROC Lumbar bolt caddy, Part Number: 81997-01-05.
Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Reason: Alphatec discovered that the lot of bolt caddies had the incorrect bolt length laser etched on one side of the caddy. The actual ROC bolts themselves are correctly laser etched.
|
2008-12-16 |
Terminated
|
View Details
|
Profile Disclaimer
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.