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 |