LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K112931
Device Name LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM
Applicant
PHYGEN, LLC
2301 dupont drive, suite 510
irvine, 
CA 
92612

Applicant Contact hartmut loch
Correspondent
PHYGEN, LLC
2301 dupont drive, suite 510
irvine, 
CA 
92612

Correspodent Contact hartmut loch
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received 10/03/2011
Decision Date 11/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No