ATLAS SPINE PEDICLE SCREW SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K072426
Device Name ATLAS SPINE PEDICLE SCREW SYSTEM
Applicant
ATLAS SPINE LLC
1555 jupiter park dr., ste. 4
jupiter, 
FL 
33458

Applicant Contact jeanette g dailey
Correspondent
ATLAS SPINE LLC
1555 jupiter park dr., ste. 4
jupiter, 
FL 
33458

Correspodent Contact jeanette g dailey
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received 08/29/2007
Decision Date 10/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls