RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM


Device Classification Name

intervertebral fusion device with integrated fixation, cervical

510(k) Number K111272
Device Name RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
Applicant
RHAUSLER, INC.
p.o. box 745039
arvada, 
CO 
80006

Applicant Contact barbara debiase
Correspondent
RHAUSLER, INC.
p.o. box 745039
arvada, 
CO 
80006

Correspodent Contact barbara debiase
Regulation Number 888.3080
Classification Product Code
OVE  
Date Received 05/04/2011
Decision Date 11/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No