PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Packaging And Manufacturing Methods Change/knee Components.

Pre-market Notification Details

• Device ID: K936292
• 510k Number: K936292
• Device Name: PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070
• Contact: Robert E Smith
• Correspondent: Robert E Smith; HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070
• Product Code: LPH
• Subsequent Product Code: JDI
• Subsequent Product Code: JWH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-12-16
• Decision Date: 1995-08-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04546540318381	K936292	000
04546540318374	K936292	000
04546540318367	K936292	000