INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K081194
Device Name INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)
Applicant
RSB SPINE LLC.
8202 sherman road
chesterland, 
OH 
44026

Applicant Contact karen e warden
Correspondent
RSB SPINE LLC.
8202 sherman road
chesterland, 
OH 
44026

Correspodent Contact karen e warden
Regulation Number 888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received 04/28/2008
Decision Date 05/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No