TETHER ACFS


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K010466
Device Name TETHER ACFS
Original Applicant
THEKEN SURGICAL,LLC
1100 nola ave.
barberton, 
OH 
44203

Original Contact robert theken
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 02/16/2001
Decision Date 05/16/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No