DURATION STABILIZED UHMWPE KNEE COMPONENTS

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Duration Stabilized Uhmwpe Knee Components.

Pre-market Notification Details

• Device ID: K972863
• 510k Number: K972863
• Device Name: DURATION STABILIZED UHMWPE KNEE COMPONENTS
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070
• Contact: Frank Maas
• Correspondent: Frank Maas; HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-08-04
• Decision Date: 1997-10-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04546540209115	K972863	000
04546540209252	K972863	000
04546540209269	K972863	000
04546540209276	K972863	000
04546540209283	K972863	000
07613153132264	K972863	000
07613154056002	K972863	000
07613154056019	K972863	000
07613154056026	K972863	000
07613154056033	K972863	000
07613154056040	K972863	000
07613154056057	K972863	000
04546540209245	K972863	000
04546540209238	K972863	000
04546540209122	K972863	000
04546540209139	K972863	000
04546540209146	K972863	000
04546540209153	K972863	000
04546540209160	K972863	000
04546540209177	K972863	000
04546540209184	K972863	000
04546540209191	K972863	000
04546540209207	K972863	000
04546540209214	K972863	000
04546540209221	K972863	000
07613154056064	K972863	000
07613154056071	K972863	000
07613327047455	K972863	000
07613327047592	K972863	000
07613327047608	K972863	000
07613327047615	K972863	000
07613327047622	K972863	000
07613327047639	K972863	000
07613327047646	K972863	000
07613327047653	K972863	000
07613327047677	K972863	000
07613327047691	K972863	000
07613327047707	K972863	000
07613327047714	K972863	000
07613327047585	K972863	000
07613327047578	K972863	000
07613327047462	K972863	000
07613327047479	K972863	000
07613327047486	K972863	000
07613327047493	K972863	000
07613327047509	K972863	000
07613327047516	K972863	000
07613327047523	K972863	000
07613327047530	K972863	000
07613327047547	K972863	000
07613327047554	K972863	000
07613327047561	K972863	000
07613327101102	K972863	000