3.7MM/5.0MM DYNAMIC LOCKING SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K110592
Device Name 3.7MM/5.0MM DYNAMIC LOCKING SCREW
Applicant
SYNTHES USA
1301 goshen pkwy
west chester, 
PA 
19380

Applicant Contact christopher hack, esq
Correspondent
SYNTHES USA
1301 goshen pkwy
west chester, 
PA 
19380

Correspodent Contact christopher hack, esq
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 03/02/2011
Decision Date 07/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls