SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K111230
Device Name SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
Applicant
SYNTHES (USA) PRODUCTS LLC
1301 goshen pkwy.
west chester, 
PA 
19380

Applicant Contact rebecca blank
Correspondent
SYNTHES (USA) PRODUCTS LLC
1301 goshen pkwy.
west chester, 
PA 
19380

Correspodent Contact rebecca blank
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 05/02/2011
Decision Date 05/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No