BIOSPINE VBR SYSTEM


Device Classification Name

spinal vertebral body replacement device

510(k) Number K110864
Device Name BIOSPINE VBR SYSTEM
Applicant
AESCULAP IMPLANT SYSTEMS, LLC
3773 corporate parkway
center valley, 
PA 
18034

Applicant Contact lisa boyle
Correspondent
AESCULAP IMPLANT SYSTEMS, LLC
3773 corporate parkway
center valley, 
PA 
18034

Correspodent Contact lisa boyle
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 03/29/2011
Decision Date 06/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No