MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K110655
Device Name MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM
Applicant
MAHE MEDICAL GMBH
schwarzwaldstrasse 5
tuttlingen, bw, 

GR

78532

Applicant Contact andrea pecsi
Correspondent
MAHE MEDICAL GMBH
schwarzwaldstrasse 5
tuttlingen, bw, 

GR

78532

Correspodent Contact andrea pecsi
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received 03/07/2011
Decision Date 10/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No