SYNTHES USS


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K111358
Device Name SYNTHES USS
Applicant
SYNTHES SPINE
1302 wrights ln east
west chester, 
PA 
19380

Applicant Contact heather guerin
Correspondent
SYNTHES SPINE
1302 wrights ln east
west chester, 
PA 
19380

Correspodent Contact heather guerin
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received 05/16/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No