PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,


the company

Device Classification Name

filler, bone void, calcium compound

510(k) Number K000515
Device Name PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,
Original Applicant
INTERPORE CROSS INTL.
181 technology dr.
irvine, 
CA 
92618 -2402

Original Contact prosie rey-fessler
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 02/16/2000
Decision Date 09/15/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No