SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS


Device Classification Name

cerclage, fixation

510(k) Number K081205
Device Name SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
Applicant
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Applicant Contact karl j nittinger
Correspondent
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Correspodent Contact karl j nittinger
Regulation Number 888.3010
Classification Product Code
JDQ  
Date Received 04/29/2008
Decision Date 07/01/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No