LINK CERAMIC HEADS 14/16 X 32MM

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 Link Ceramic Heads 14/16 X 32mm.

Pre-market Notification Details

Device IDK931572
510k NumberK931572
Device Name:LINK CERAMIC HEADS 14/16 X 32MM
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant LINK AMERICA, INC. 321 PALMER RD. Denville,  NJ  07834
ContactJonathan Martinek
CorrespondentJonathan Martinek
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 Received1993-03-30
Decision Date1994-03-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04026575027330 K931572 000
04026575027323 K931572 000
04026575027316 K931572 000

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