SYNTHES USS, CLICK’X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K022949
Device Name SYNTHES USS, CLICK’X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
Original Applicant
SYNTHES (USA)
1690 russell rd.
paoli, 
PA 
19301

Original Contact vikki m hoffman
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received 09/05/2002
Decision Date 03/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No