COFLEX-F


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K112595
Device Name COFLEX-F
Applicant
PARADIGM SPINE, LLC
505 park avenue, 14th floor
new york, 
NY 
10022

Applicant Contact marc viscogliosi
Correspondent
PARADIGM SPINE, LLC
505 park avenue, 14th floor
new york, 
NY 
10022

Correspodent Contact marc viscogliosi
Regulation Number 888.3050
Classification Product Code
KWP  
Date Received 09/07/2011
Decision Date 02/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No