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
|
|
Correspondent Contact |
TRAVIS AROLA |
Regulation Number | 888.3045
|
Classification Product Code |
|
Subsequent Product Code |
|
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
|
|
|