Titanium Interference Screws

Screw, Fixation, Bone

Biomet Inc.

The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Titanium Interference Screws.

Pre-market Notification Details

Device IDK193451
510k NumberK193451
Device Name:Titanium Interference Screws
ClassificationScrew, Fixation, Bone
Applicant Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw,  IN  46581
ContactSaveetha Raghupathi
CorrespondentSaveetha Raghupathi
Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw,  IN  46581
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-13
Decision Date2020-02-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304412149 K193451 000
00880304005532 K193451 000
00880304002791 K193451 000
00880304002685 K193451 000
00880304002593 K193451 000
00880304002579 K193451 000
00880304002562 K193451 000
00880304002555 K193451 000
00880304008458 K193451 000
00880304008304 K193451 000
00880304008311 K193451 000
00880304008465 K193451 000
00880304412118 K193451 000
00880304412101 K193451 000
00880304412071 K193451 000
00880304412040 K193451 000
00880304412026 K193451 000
00880304412002 K193451 000
00880304411999 K193451 000
00880304411937 K193451 000
00880304412132 K193451 000

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