CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K081107
Device Name CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
Applicant
K2M, INC.
751 miller dr.,se
leesburg, 
VA 
20175

Applicant Contact richard w woods
Correspondent
K2M, INC.
751 miller dr.,se
leesburg, 
VA 
20175

Correspodent Contact richard w woods
Regulation Number 888.3050
Classification Product Code
KWP  
Date Received 04/18/2008
Decision Date 10/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No