FIXXSURE CROSS LINK


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K081331
Device Name FIXXSURE CROSS LINK
Applicant
SPINEWORKS, LLC
1001 oakwood blvd.
round rock, 
TX 
78681

Applicant Contact j.d. webb
Correspondent
SPINEWORKS, LLC
1001 oakwood blvd.
round rock, 
TX 
78681

Correspodent Contact j.d. webb
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received 05/12/2008
Decision Date 07/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No