SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE …


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K112607
Device Name SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE …
Applicant
SPINEVISION, S.A.
111 hill road
douglassville, 
PA 
19518

Applicant Contact donald w guthner
Correspondent
SPINEVISION, S.A.
111 hill road
douglassville, 
PA 
19518

Correspodent Contact donald w guthner
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received 09/07/2011
Decision Date 06/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No