GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5


Device Classification Name

system, facet screw spinal device

510(k) Number K112097
Device Name GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Applicant Contact vladislava zaitseva
Correspondent
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Correspodent Contact vladislava zaitseva
Classification Product Code
MRW  
Date Received 07/22/2011
Decision Date 11/21/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No