STERISPINEPS PEDICLE SCREW


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K112453
Device Name STERISPINEPS PEDICLE SCREW
Applicant
SAFE ORTHOPAEDICS
parc des bellevues- allee
r luxembourg-bat californie
eragny sur oise, 

FR

95610

Applicant Contact pierre dumouchel
Correspondent
SAFE ORTHOPAEDICS
parc des bellevues- allee
r luxembourg-bat californie
eragny sur oise, 

FR

95610

Correspodent Contact pierre dumouchel
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received 08/25/2011
Decision Date 11/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No