LUCENT OR LUCENT MAGNUM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K110632
Device Name LUCENT OR LUCENT MAGNUM
Applicant
SPINAL ELEMENTS, INC.
2744 loker ave. w. suite 100
carlsbad, 
CA 
90210

Applicant Contact benjamin a kimball
Correspondent
SPINAL ELEMENTS, INC.
2744 loker ave. w. suite 100
carlsbad, 
CA 
90210

Correspodent Contact benjamin a kimball
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 03/04/2011
Decision Date 05/23/2012
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