STREAMLINE TL SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K110692
Device Name STREAMLINE TL SPINAL SYSTEM
Applicant
PIONEER SURGICAL TECHNOLOGY, INC.
375 river park circle
marquette, 
MI 
49855

Applicant Contact emily m downs
Correspondent
PIONEER SURGICAL TECHNOLOGY, INC.
375 river park circle
marquette, 
MI 
49855

Correspodent Contact emily m downs
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received 03/11/2011
Decision Date 05/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No