FELDMUHLE CERAMIC HEAD

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

LINK AMERICA, INC.

The following data is part of a premarket notification filed by Link America, Inc. with the FDA for Feldmuhle Ceramic Head.

Pre-market Notification Details

Device IDK920756
510k NumberK920756
Device Name:FELDMUHLE CERAMIC HEAD
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant LINK AMERICA, INC. 321 PALMER RD. Denville,  NJ  07834
ContactEdward B Schussler
CorrespondentEdward B Schussler
LINK AMERICA, INC. 321 PALMER RD. Denville,  NJ  07834
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-02-19
Decision Date1992-05-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04026575365289 K920756 000
04026575028245 K920756 000
04026575028252 K920756 000
04026575359080 K920756 000
04026575359097 K920756 000
04026575359103 K920756 000
04026575365203 K920756 000
04026575365210 K920756 000
04026575365227 K920756 000
04026575365234 K920756 000
04026575365241 K920756 000
04026575365258 K920756 000
04026575028238 K920756 000

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