SYNTHES ZERO-P VARIABLE ANGLE (VA)


Device Classification Name

intervertebral fusion device with integrated fixation, cervical

510(k) Number K112068
Device Name SYNTHES ZERO-P VARIABLE ANGLE (VA)
Applicant
SYNTHES SPINE CO.LP
1302 wrights lane east
west chester, 
PA 
19380

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

Correspodent Contact stacey bonnell
Regulation Number 888.3080
Classification Product Code
OVE  
Date Received 07/20/2011
Decision Date 11/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls