PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT


Device Classification Name

filler, bone void, calcium compound

510(k) Number K072597
Device Name PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Applicant Contact ryan m belaney
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Correspodent Contact ryan m belaney
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 09/14/2007
Decision Date 10/15/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No