OCTANE-C INTERBODY FUSION DEVICE SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K103655
Device Name OCTANE-C INTERBODY FUSION DEVICE SYSTEM
Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

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

Correspodent Contact patrick hughes
Regulation Number 888.3080
Classification Product Code
ODP  
Date Received 12/15/2010
Decision Date 06/30/2011
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