SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS


Device Classification Name

neurological stereotaxic instrument

510(k) Number K122211
Device Name SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
Applicant
SYNTHES SPINE
1302 wrights ln east
west chester, 
PA 
19380

Applicant Contact hemal mehta
Correspondent
SYNTHES SPINE
1302 wrights ln east
west chester, 
PA 
19380

Correspodent Contact hemal mehta
Regulation Number 882.4560
Classification Product Code
HAW  
Subsequent Product Code
OLO  
Date Received 07/25/2012
Decision Date 12/17/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No