SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K073402
Device Name SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM
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 888.3020
Classification Product Code
HSB  
Date Received 12/04/2007
Decision Date 02/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No