SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K081395
Device Name SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM
Applicant
BIOMET SPINE
100 interpace parkway
parsippany, 
NJ 
07054

Applicant Contact vivian kelly
Correspondent
BIOMET SPINE
100 interpace parkway
parsippany, 
NJ 
07054

Correspodent Contact vivian kelly
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 05/19/2008
Decision Date 06/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No