PMA P960053S002

Device: TOTAL TRAPEZIO METACARPAL PROSTHESIS
Applicant: Stryker Corporation
PMA number: P960053
Supplement: S002
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: S002
Product code: KWG
Generic name: Prosthesis, finger, constrained, metal/polymer
Decision date: 1998-06-04
Decision code: APPR
Date received: 1998-04-16
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.