SYNTHES PROXIMAL HUMERAL NAIL


definition

Device Classification Name

nail, fixation, bone

510(k) Number K002729
Device Name SYNTHES PROXIMAL HUMERAL NAIL
Original Applicant
SYNTHES (USA)
1690 russell rd.
paoli, 
PA 
19301

Original Contact thomas m maguire
Regulation Number 888.3030
Classification Product Code
JDS  
Date Received 09/01/2000
Decision Date 10/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No