ARROW REVERSE SHOULDER SYSTEM


Device Classification Name

prosthesis, shoulder, semi-constrained, metal/polymer cemented

510(k) Number K112193
Device Name ARROW REVERSE SHOULDER SYSTEM
Applicant
FOURNITURES HOSPITALIERES INDUSTRIE
zi de kernevez-6 rue nobel
quimper, 

FR

29000

Applicant Contact patricia donnard
Correspondent
FOURNITURES HOSPITALIERES INDUSTRIE
zi de kernevez-6 rue nobel
quimper, 

FR

29000

Correspodent Contact patricia donnard
Regulation Number 888.3660
Classification Product Code
KWS  
Subsequent Product Code
KWT  
Date Received 07/29/2011
Decision Date 07/12/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No