EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K022419
Device Name EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
Original Applicant
EBI, L.P.
399 jefferson road
parsippany, 
NJ 
07054

Original Contact jon caparotta
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 07/24/2002
Decision Date 08/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No