OSTEOSET DBM PELLETS, MODEL 8600-48XX


Device Classification Name

filler, bone void, calcium compound

510(k) Number K022828
Device Name OSTEOSET DBM PELLETS, MODEL 8600-48XX
Original Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Original Contact roger d brown
Regulation Number 888.3045
Classification Product Code
MQV  
Subsequent Product Code
MBP  
Date Received 08/26/2002
Decision Date 04/02/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No