The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Sbf System (sbf).
Device ID | K911936 |
510k Number | K911936 |
Device Name: | OSTEOMED SBF SYSTEM (SBF) |
Classification | Screw, Fixation, Intraosseous |
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 | DZL |
CFR Regulation Number | 872.4880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-01 |
Decision Date | 1991-08-21 |