OSTEOMED QUICKFIX

Screw, Fixation, Intraosseous

OSTEOMED CORP.

The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Quickfix.

Pre-market Notification Details

Device IDK962774
510k NumberK962774
Device Name:OSTEOMED QUICKFIX
ClassificationScrew, Fixation, Intraosseous
Applicant OSTEOMED CORP. 3150 PREMIER DR. #110 Irving,  TX  75063
ContactJames D Lafferty
CorrespondentJames D Lafferty
OSTEOMED CORP. 3150 PREMIER DR. #110 Irving,  TX  75063
Product CodeDZL  
CFR Regulation Number872.4880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-16
Decision Date1997-10-10

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