DISCOVERY


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K111484
Device Name DISCOVERY
Applicant
INTUITIVE SPINE, LLC
33490 pin oak parkway
avon lake, 
OH 
44012

Applicant Contact jennifer palinchik
Correspondent
INTUITIVE SPINE, LLC
33490 pin oak parkway
avon lake, 
OH 
44012

Correspodent Contact jennifer palinchik
Regulation Number 888.3080
Classification Product Code
ODP  
Date Received 05/31/2011
Decision Date 09/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No