BIOSET XCH


Device Classification Name

filler, bone void, calcium compound

510(k) Number K072238
Device Name BIOSET XCH
Applicant
REGENERATION TECHNOLOGIES, INC.
11621 research cir.
p.o. box 2650
alachua, 
FL 
32616 -2650

Applicant Contact travis arola
Correspondent
REGENERATION TECHNOLOGIES, INC.
11621 research cir.
p.o. box 2650
alachua, 
FL 
32616 -2650

Correspodent Contact travis arola
Regulation Number 888.3045
Classification Product Code
MQV  
Subsequent Product Code
MPB  
Date Received 08/13/2007
Decision Date 01/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No