The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed M3 System (sbf System).
| Device ID | K924138 |
| 510k Number | K924138 |
| Device Name: | OSTEOMED M3 SYSTEM (SBF SYSTEM) |
| Classification | Plate, Bone |
| Applicant | OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale, CA 91202 |
| Contact | Rick A Buss |
| Correspondent | Rick A Buss OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale, CA 91202 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-18 |
| Decision Date | 1993-02-17 |