RESORBABLE INTERFERENCE SCREW

Screw, Fixation, Bone

ARTHROTEK, INC.

The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Resorbable Interference Screw.

Pre-market Notification Details

Device IDK041274
510k NumberK041274
Device Name:RESORBABLE INTERFERENCE SCREW
ClassificationScrew, Fixation, Bone
Applicant ARTHROTEK, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactGary Baker
CorrespondentGary Baker
ARTHROTEK, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-12
Decision Date2004-07-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304443280 K041274 000
00880304421028 K041274 000
00880304421011 K041274 000
00880304421004 K041274 000
00880304010901 K041274 000
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00880304005167 K041274 000
00880304004023 K041274 000
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00880304002814 K041274 000
00880304421035 K041274 000
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00880304421059 K041274 000
00880304443273 K041274 000
00880304443266 K041274 000
00880304443259 K041274 000
00880304443242 K041274 000
00880304432543 K041274 000
00880304432192 K041274 000
00880304432185 K041274 000
00880304432178 K041274 000
00880304421073 K041274 000
00880304421066 K041274 000
00880304002012 K041274 000

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