PATELLAR TENDON GRAFT GUIDE

Orthopedic Manual Surgical Instrument

CONCEPT, INC.

The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Patellar Tendon Graft Guide.

Pre-market Notification Details

Device IDK880413
510k NumberK880413
Device Name:PATELLAR TENDON GRAFT GUIDE
ClassificationOrthopedic Manual Surgical Instrument
Applicant CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater,  FL  33546
ContactMartha C Miller
CorrespondentMartha C Miller
CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater,  FL  33546
Product CodeLXH  
CFR Regulation Number888.4540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-01
Decision Date1988-03-04

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