EXACTECH GIBRALT SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K110197
Device Name EXACTECH GIBRALT SPINAL SYSTEM
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
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received 01/24/2011
Decision Date 07/15/2011
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