IVAS 2-10MM (10 GUAGE) BALLON CATHETER


Device Classification Name

cement, bone, vertebroplasty

510(k) Number K103807
Device Name IVAS 2-10MM (10 GUAGE) BALLON CATHETER
Applicant
STRYKER CORPORATION
4100 e. milham ave
kalamazoo, 
MI 
49001

Applicant Contact melissa kann
Correspondent
STRYKER CORPORATION
4100 e. milham ave
kalamazoo, 
MI 
49001

Correspodent Contact melissa kann
Regulation Number 888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received 12/29/2010
Decision Date 06/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No