XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K080928
Device Name XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS
Applicant
STRYKER SPINE
2 pearl court
allendale, 
NJ 
07401

Applicant Contact curtis truesdale
Correspondent
STRYKER SPINE
2 pearl court
allendale, 
NJ 
07401

Correspodent Contact curtis truesdale
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received 04/02/2008
Decision Date 04/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No