The following data is part of a premarket notification filed by Onyx Medical Corp. with the FDA for Combination Reamer.
| Device ID | K903248 |
| 510k Number | K903248 |
| Device Name: | COMBINATION REAMER |
| Classification | Reamer |
| Applicant | ONYX MEDICAL CORP. 152 COLLINS ST. Memphis, TN 38112 |
| Contact | George W Murray |
| Correspondent | George W Murray ONYX MEDICAL CORP. 152 COLLINS ST. Memphis, TN 38112 |
| Product Code | HTO |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-24 |
| Decision Date | 1990-07-30 |