GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K111132
Device Name GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM
Applicant
GENESYS SPINE
1250 capital of texas hwy so.
building three, suite 600
austin, 
TX 
78746

Applicant Contact brian j bergeron
Correspondent
GENESYS SPINE
1250 capital of texas hwy so.
building three, suite 600
austin, 
TX 
78746

Correspodent Contact brian j bergeron
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 04/22/2011
Decision Date 12/09/2011
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