PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM

Fastener, Fixation, Biodegradable, Soft Tissue

ETHICON, INC.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Panalok Wedge Absorable Suture Anchor System.

Pre-market Notification Details

Device IDK952687
510k NumberK952687
Device Name:PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville,  NJ  08876
ContactJohn D Paulson
CorrespondentJohn D Paulson
ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville,  NJ  08876
Product CodeMAI  
Subsequent Product CodeHRX
Subsequent Product CodeMBI
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-12
Decision Date1996-02-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886705000982 K952687 000

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