PREMIER-TOTAL (TM) HIP

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Premier-total (tm) Hip.

Pre-market Notification Details

Device IDK873999
510k NumberK873999
Device Name:PREMIER-TOTAL (TM) HIP
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactThomas L Craig
CorrespondentThomas L Craig
INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-01
Decision Date1987-10-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024174542 K873999 000
00889024174467 K873999 000
00889024174474 K873999 000
00889024174481 K873999 000
00889024174498 K873999 000
00889024174504 K873999 000
00889024174511 K873999 000
00889024174528 K873999 000
00889024174535 K873999 000
00889024174450 K873999 000

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