UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE

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

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Uhmwpe Hip And Knee Components - Packaging Change.

Pre-market Notification Details

Device IDK964655
510k NumberK964655
Device Name:UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactJohn Dichiara
CorrespondentJohn Dichiara
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeJDI  
Subsequent Product CodeJDL
Subsequent Product CodeJWH
Subsequent Product CodeLPH
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-20
Decision Date1997-02-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04546540323163 K964655 000
04546540319449 K964655 000
04546540319432 K964655 000
04546540319425 K964655 000
04546540319418 K964655 000
04546540319401 K964655 000
04546540319395 K964655 000
04546540319388 K964655 000
04546540319371 K964655 000
04546540319364 K964655 000
04546540319357 K964655 000
04546540319456 K964655 000
04546540319463 K964655 000
04546540323019 K964655 000
04546540322869 K964655 000
04546540319548 K964655 000
04546540319531 K964655 000
04546540319524 K964655 000
04546540319517 K964655 000
04546540319500 K964655 000
04546540319494 K964655 000
04546540319487 K964655 000
04546540319470 K964655 000
04546540319340 K964655 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.