GAP ENDO-EXO MEDULLARY SYSTEM


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K111232
Device Name GAP ENDO-EXO MEDULLARY SYSTEM
Applicant
PEGA MEDICAL INC.
1111 autoroute chomedey
laval, 

CA

h7w 5j8

Applicant Contact ariel r dujovne
Correspondent
PEGA MEDICAL INC.
1111 autoroute chomedey
laval, 

CA

h7w 5j8

Correspodent Contact ariel r dujovne
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 05/02/2011
Decision Date 01/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls