M3 LAG SCREW FIXATION SYSTEM

Screw, Fixation, Bone

OSTEOMED CORP.

The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for M3 Lag Screw Fixation System.

Pre-market Notification Details

Device IDK924018
510k NumberK924018
Device Name:M3 LAG SCREW FIXATION SYSTEM
ClassificationScrew, Fixation, Bone
Applicant OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale,  CA  91202
ContactSteven C Pubols
CorrespondentSteven C Pubols
OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale,  CA  91202
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-11
Decision Date1993-04-01

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