MENDEC SPINE HV, MENDEC SPINE HV SYSTEM


Device Classification Name

cement, bone, vertebroplasty

510(k) Number K122175
Device Name MENDEC SPINE HV, MENDEC SPINE HV SYSTEM
Applicant
TECRES SPA
7 trail house court
rockville, 
MD 
20850

Applicant Contact christine brauer, ph.d.
Correspondent
TECRES SPA
7 trail house court
rockville, 
MD 
20850

Correspodent Contact christine brauer, ph.d.
Regulation Number 888.3027
Classification Product Code
NDN  
Subsequent Product Code
LOD  
Date Received 07/23/2012
Decision Date 03/28/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No