SYNTHES OC FUSION AND SYNAPSE SYSTEMS


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K072434
Device Name SYNTHES OC FUSION AND SYNAPSE SYSTEMS
Applicant
SYNTHES SPINE CO.LP
1302 wrights lane east
west chester, 
PA 
19380

Applicant Contact susan lewandowski
Correspondent
SYNTHES SPINE CO.LP
1302 wrights lane east
west chester, 
PA 
19380

Correspodent Contact susan lewandowski
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received 08/29/2007
Decision Date 01/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No