TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)


Device Classification Name

filler, bone void, calcium compound

510(k) Number K110787
Device Name TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)
Applicant
ORTHOGEM LIMITED
biocity, pennyfoot street
nottingham, 

GB

ng1 1gf

Applicant Contact we-jen lo
Correspondent
ORTHOGEM LIMITED
biocity, pennyfoot street
nottingham, 

GB

ng1 1gf

Correspodent Contact we-jen lo
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 03/21/2011
Decision Date 04/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No