CRYSTAL


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K073351
Device Name CRYSTAL
Applicant
SPINAL ELEMENTS, INC.
2744 loker ave. w. suite 100
carlsbad, 
CA 
92010

Applicant Contact kerri dimartino
Correspondent
SPINAL ELEMENTS, INC.
2744 loker ave. w. suite 100
carlsbad, 
CA 
92010

Correspodent Contact kerri dimartino
Regulation Number 888.3080
Classification Product Code
ODP  
Date Received 11/29/2007
Decision Date 01/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No