LAGUNA SIZE 8 PEDICLE SCREW


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K072678
Device Name LAGUNA SIZE 8 PEDICLE SCREW
Applicant
ALLEZ SPINE, LLC
2301 dupont drive, suite 510
irvine, 
CA 
92612

Applicant Contact hartmut loch
Correspondent
ALLEZ SPINE, 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   MNH   MNI  
Date Received 09/21/2007
Decision Date 07/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No