BOX PEEK VBR SYSTEM,


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K121581
Device Name BOX PEEK VBR SYSTEM,
Applicant
INNOVASIS, INC.
614 east 3900 south
salt lake city, 
UT 
84107

Applicant Contact marshall c mccarty
Correspondent
INNOVASIS, INC.
614 east 3900 south
salt lake city, 
UT 
84107

Correspodent Contact marshall c mccarty
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 05/30/2012
Decision Date 10/17/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No