TWIN PEAKS LUMBAR CAGE


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K112696
Device Name TWIN PEAKS LUMBAR CAGE
Applicant
QUALGENIX LLC
1 jack’s hill road
unit 3e
oxford, 
CT 
06478

Applicant Contact richard deslauriers
Correspondent
QUALGENIX LLC
1 jack’s hill road
unit 3e
oxford, 
CT 
06478

Correspodent Contact richard deslauriers
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 09/15/2011
Decision Date 04/18/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No