ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K072183
Device Name ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600
Applicant
ZIMMER SPINE, INC.
7375 bush lake rd.
minneapolis, 
MN 
55439

Applicant Contact tim crabtree
Correspondent
ZIMMER SPINE, INC.
7375 bush lake rd.
minneapolis, 
MN 
55439

Correspodent Contact tim crabtree
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received 08/06/2007
Decision Date 09/05/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No