AUGMENT AND SCREW, PSA TYPE


Device Classification Name

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

510(k) Number K122183
Device Name AUGMENT AND SCREW, PSA TYPE
Applicant
UNITED ORTHOPEDIC CORP.
57 park ave. 2, science park
hsinchu, 

TW

300

Applicant Contact fang-yuan ho
Correspondent
UNITED ORTHOPEDIC CORP.
57 park ave. 2, science park
hsinchu, 

TW

300

Correspodent Contact fang-yuan ho
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 07/23/2012
Decision Date 02/05/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No