The following data is part of a premarket notification filed by Onyx Medical Corp. with the FDA for 1/4 Tubular Plate.
| Device ID | K931694 |
| 510k Number | K931694 |
| Device Name: | 1/4 TUBULAR PLATE |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-05 |
| Decision Date | 1994-04-25 |