The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for M3 Lag Screw Fixation System.
| Device ID | K924018 |
| 510k Number | K924018 |
| Device Name: | M3 LAG SCREW FIXATION SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale, CA 91202 |
| Contact | Steven C Pubols |
| Correspondent | Steven C Pubols OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale, CA 91202 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-11 |
| Decision Date | 1993-04-01 |