OSTEONICS RESTORATION ACETABULAR RING

Mesh, Surgical, Acetabular, Hip, Prosthesis

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Restoration Acetabular Ring.

Pre-market Notification Details

Device IDK970957
510k NumberK970957
Device Name:OSTEONICS RESTORATION ACETABULAR RING
ClassificationMesh, Surgical, Acetabular, Hip, Prosthesis
Applicant OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
ContactKate Sutton
CorrespondentKate Sutton
OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
Product CodeJDJ  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-17
Decision Date1997-06-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327017731 K970957 000
07613327017724 K970957 000
07613327017700 K970957 000
07613327017694 K970957 000
07613327017687 K970957 000
07613327017670 K970957 000
07613327017663 K970957 000

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