The following data is part of a premarket notification filed by Onyx Medical Corp. with the FDA for Malleolar Screw.
| Device ID | K931686 |
| 510k Number | K931686 |
| Device Name: | MALLEOLAR SCREW |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | ONYX MEDICAL CORP. 152 COLLINS ST. Memphis, TN 38112 |
| Contact | Laraine B Gilmore |
| Correspondent | Laraine B Gilmore ONYX MEDICAL CORP. 152 COLLINS ST. Memphis, TN 38112 |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-05 |
| Decision Date | 1994-04-05 |