MONT BLANC PEDICLE SCREW SYSTEMS


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K112684
Device Name MONT BLANC PEDICLE SCREW SYSTEMS
Applicant
QUALGENIX
1 jack’s hill road
unit 3e
oxford, 
CT 
06478

Applicant Contact richard deslauriers
Correspondent
QUALGENIX
1 jack’s hill road
unit 3e
oxford, 
CT 
06478

Correspodent Contact richard deslauriers
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received 09/15/2011
Decision Date 05/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No