SCIENT’X TRIBECA VBR


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K080588
Device Name SCIENT’X TRIBECA VBR
Applicant
SCIENT’X USA, INC.
1015 maitland center commons
suite 106a
maitland, 
FL 
32751

Applicant Contact john sanders
Correspondent
SCIENT’X USA, INC.
1015 maitland center commons
suite 106a
maitland, 
FL 
32751

Correspodent Contact john sanders
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 03/03/2008
Decision Date 05/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No