HCL ACETABULAR COMPONENTS

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Hcl Acetabular Components.

Pre-market Notification Details

Device IDK803192
510k NumberK803192
Device Name:HCL ACETABULAR COMPONENTS
ClassificationProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Applicant OSTEONICS CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKWZ  
CFR Regulation Number888.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-12-16
Decision Date1981-01-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327101676 K803192 000
07613327038415 K803192 000
07613327038408 K803192 000
07613327038392 K803192 000
07613327038385 K803192 000
07613327038378 K803192 000
07613327038361 K803192 000
07613327038354 K803192 000
07613327032598 K803192 000
07613327032581 K803192 000
07613327032574 K803192 000
07613327032567 K803192 000
07613327032550 K803192 000
07613327032543 K803192 000
07613327038422 K803192 000
07613327038439 K803192 000
07613327039184 K803192 000
07613327039177 K803192 000
07613327038545 K803192 000
07613327038538 K803192 000
07613327038521 K803192 000
07613327038514 K803192 000
07613327038507 K803192 000
07613327038491 K803192 000
07613327038484 K803192 000
07613327038477 K803192 000
07613327038460 K803192 000
07613327038453 K803192 000
07613327038446 K803192 000
07613327032536 K803192 000

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