MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM


information about

Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K000513
Device Name MODIFICATION TO 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 02/16/2000
Decision Date 03/07/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Special
Reviewed by Third Party No

Combination Product

No