SYNTHES SCOUT TACK FIXATION


Device Classification Name

vessel guard or cover

510(k) Number K111048
Device Name SYNTHES SCOUT TACK FIXATION
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 870.3470
Classification Product Code
OMR  
Subsequent Product Code
NDM  
Date Received 04/15/2011
Decision Date 06/14/2012
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No