SMARTLOC SPINAL FIXATION SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K111883
Device Name SMARTLOC SPINAL FIXATION SYSTEM
Applicant
A-SPINE ASIA, CO., LTD
11f., no. 1, aly. 30, ln. 358
ruiguang rd.
taipei, neihu district, 

TW

11492

Applicant Contact frank hsu
Correspondent
A-SPINE ASIA, CO., LTD
11f., no. 1, aly. 30, ln. 358
ruiguang rd.
taipei, neihu district, 

TW

11492

Correspodent Contact frank hsu
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received 07/01/2011
Decision Date 10/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No