CHESAPEAKE (CERVICAL COMPONENTS)


Device Classification Name

intervertebral fusion device with integrated fixation, cervical

510(k) Number K111439
Device Name CHESAPEAKE (CERVICAL COMPONENTS)
Applicant
K2M, INC.
751 miller dr.,se
leesburg, 
VA 
20175

Applicant Contact nancy giezen
Correspondent
K2M, INC.
751 miller dr.,se
leesburg, 
VA 
20175

Correspodent Contact nancy giezen
Regulation Number 888.3080
Classification Product Code
OVE  
Date Received 05/24/2011
Decision Date 08/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No