SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS


Device Classification Name

nail, fixation, bone

510(k) Number K111667
Device Name SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
Applicant
SYNTHES (USA)
1301 goshen pkwy.
west chester, 
PA 
19380

Applicant Contact christopher hack
Correspondent
SYNTHES (USA)
1301 goshen pkwy.
west chester, 
PA 
19380

Correspodent Contact christopher hack
Regulation Number 888.3030
Classification Product Code
JDS  
Date Received 06/14/2011
Decision Date 12/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls