TI - SCREW ANCHOR SP

Fastener, Fixation, Nondegradable, Soft Tissue

ARTHROTEK, INC.

The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Ti - Screw Anchor Sp.

Pre-market Notification Details

Device IDK042460
510k NumberK042460
Device Name:TI - SCREW ANCHOR SP
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ARTHROTEK, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactGary Baker
CorrespondentGary Baker
ARTHROTEK, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeMBI  
Subsequent Product CodeGAS
Subsequent Product CodeGAT
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-10
Decision Date2004-10-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304563698 K042460 000
00880304453432 K042460 000
00880304453449 K042460 000
00880304453463 K042460 000
00880304453470 K042460 000
00880304464186 K042460 000
00880304464193 K042460 000
00880304464315 K042460 000
00880304464544 K042460 000
00880304464896 K042460 000
00880304465466 K042460 000
00880304563681 K042460 000
00880304444263 K042460 000

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