Known Identifiers & Locations
FEI Numbers
N/A
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 (4)
| Submission # |
Device Name |
Decision Date |
Decision Description |
Action |
| K030390 |
SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE |
2003-04-01 |
Substantially Equivalent |
View Details
|
| K040336 |
SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM |
2004-04-12 |
Substantially Equivalent |
View Details
|
| K063832 |
SYNTHES (USA) ELBOW HINGE FIXATOR |
2007-03-07 |
Substantially Equivalent |
View Details
|
| K952296 |
SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW |
1995-08-18 |
Substantially Equivalent |
View Details
|
FDA Recall History (0)
No recall records found for this entity.
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.