OSTEOMED SBF SYSTEM (SBF)

Screw, Fixation, Intraosseous

OSTEOMED CORP.

The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Sbf System (sbf).

Pre-market Notification Details

Device IDK911936
510k NumberK911936
Device Name:OSTEOMED SBF SYSTEM (SBF)
ClassificationScrew, Fixation, Intraosseous
Applicant OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale,  CA  91202
ContactRick A Buss
CorrespondentRick A Buss
OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale,  CA  91202
Product CodeDZL  
CFR Regulation Number872.4880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-01
Decision Date1991-08-21

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