FOCUS MIS SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K112643
Device Name FOCUS MIS SYSTEM
Applicant
L & K BIOMED CO., LTD
room 1104, ace high-end tower3
371-50 gasan-dong, geumcheon-g
seoul, 

KR

153803

Applicant Contact hee k joo
Correspondent
L & K BIOMED CO., LTD
room 1104, ace high-end tower3
371-50 gasan-dong, geumcheon-g
seoul, 

KR

153803

Correspodent Contact hee k joo
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received 09/12/2011
Decision Date 01/04/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No