MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K080690
Device Name MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM
Applicant
THEKEN SPINE LLC
1800 triplett blvd.
akron, 
OH 
44306

Applicant Contact dale davison
Correspondent
THEKEN SPINE LLC
1800 triplett blvd.
akron, 
OH 
44306

Correspodent Contact dale davison
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 03/11/2008
Decision Date 04/25/2008
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