DEPUY LOW PROFILE BONE SCREW

Screw, Fixation, Bone

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Low Profile Bone Screw.

Pre-market Notification Details

Device IDK970929
510k NumberK970929
Device Name:DEPUY LOW PROFILE BONE SCREW
ClassificationScrew, Fixation, Bone
Applicant DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
ContactSally Foust
CorrespondentSally Foust
DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-13
Decision Date1997-06-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295007708 K970929 000
10603295007609 K970929 000
10603295007616 K970929 000
10603295007623 K970929 000
10603295007630 K970929 000
10603295007647 K970929 000
10603295007654 K970929 000
10603295007661 K970929 000
10603295007678 K970929 000
10603295007685 K970929 000
10603295007692 K970929 000
10603295007593 K970929 000

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