FS 1000 KNEE SYSTEM


Device Classification Name

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer

510(k) Number K991052
Device Name FS 1000 KNEE SYSTEM
Applicant
RENAISSANCE INSTRUMENTS, LLC.
370 ninth ave., suite 205
salt lake city, 
UT 
84103

Applicant Contact kent m samuelson
Correspondent
RENAISSANCE INSTRUMENTS, LLC.
370 ninth ave., suite 205
salt lake city, 
UT 
84103

Correspodent Contact kent m samuelson
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 03/30/1999
Decision Date 11/10/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No