G-FORCE PEEK SUTURE ANCHOR SYSTEM

Fastener, Fixation, Nondegradable, Soft Tissue

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for G-force Peek Suture Anchor System.

Pre-market Notification Details

Device IDK100630
510k NumberK100630
Device Name:G-FORCE PEEK SUTURE ANCHOR SYSTEM
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
ContactKellen Hills
CorrespondentKellen Hills
WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-05
Decision Date2010-06-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420142801 K100630 000
00840420142795 K100630 000

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