OSSEOFLEX SB INFLATABLE BONE TAMP


Device Classification Name

cement, bone, vertebroplasty

510(k) Number K122533
Device Name OSSEOFLEX SB INFLATABLE BONE TAMP
Applicant
OSSEON THERAPEUTICS, INC.
2330 circadian way
santa rosa, 
CA 
95407

Applicant Contact keith burger
Correspondent
OSSEON THERAPEUTICS, INC.
2330 circadian way
santa rosa, 
CA 
95407

Correspodent Contact keith burger
Regulation Number 888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received 08/20/2012
Decision Date 10/23/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No