PMA P960053S001

Device: TOTAL TRAPEZIO METACARPAL PROSTHESIS
Applicant: Stryker Corporation
PMA number: P960053
Supplement: S001
Product code: KWG
Decision date: 1998-06-04
Generic name: Prosthesis, finger, constrained, metal/polymer
Approval order statement: APPROVAL FOR 1) PACKAGING THE IMPLANT IN A SINGLE BOX CONTAINING BOTH THE PROXIMAL AND DISTAL COMPONENTS AND CHANGING PACKAGE LABELS ACCORDINGLY, AND 2) CHANGING THE COLOR OF STOCK USED FOR PRINTING BOX LABELS.

Current openFDA PMA Record#

Device: TOTAL TRAPEZIO METACARPAL PROSTHESIS
Applicant: Stryker Corporation
PMA number: P960053
Supplement: S001
Product code: KWG
Generic name: Prosthesis, finger, constrained, metal/polymer
Decision date: 1998-06-04
Decision code: APPR
Date received: 1998-03-31
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR 1) PACKAGING THE IMPLANT IN A SINGLE BOX CONTAINING BOTH THE PROXIMAL AND DISTAL COMPONENTS AND CHANGING PACKAGE LABELS ACCORDINGLY, AND 2) CHANGING THE COLOR OF STOCK USED FOR PRINTING BOX LABELS.