SYNTHES XRL


Device Classification Name

spinal vertebral body replacement device

510(k) Number K103320
Device Name SYNTHES XRL
Applicant
SYNTHES SPINE CO.LP
1302 wrights lane east
west chester, 
PA 
19380

Applicant Contact heather guerin
Correspondent
SYNTHES SPINE CO.LP
1302 wrights lane east
west chester, 
PA 
19380

Correspodent Contact heather guerin
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 11/12/2010
Decision Date 10/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls