The following data is part of a premarket notification filed by Gold Standard Orthopaedics Llc with the FDA for Gso Bone Fixation Fasteners.
| Device ID | K063589 |
| 510k Number | K063589 |
| Device Name: | GSO BONE FIXATION FASTENERS |
| Classification | Screw, Fixation, Bone |
| Applicant | GOLD STANDARD ORTHOPAEDICS LLC 1226 WEST ROWAN ST. Louisville, KY 40203 |
| Contact | David Baughman |
| Correspondent | David Baughman GOLD STANDARD ORTHOPAEDICS LLC 1226 WEST ROWAN ST. Louisville, KY 40203 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-01 |
| Decision Date | 2007-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M9935011251 | K063589 | 000 |
| M9935011250 | K063589 | 000 |