Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K190371 |
Device Name |
Morpheus-C |
Applicant |
Biogennix, LLC. |
1641 McGaw Ave |
Irvine,
CA
92614
|
|
Applicant Contact |
Timothy Bumbalough |
Correspondent |
Paladin Medical, Inc. |
PO Box 560 |
Stillwater,
MN
55082
|
|
Correspondent Contact |
Elaine Duncan |
Regulation Number | 888.3045 |
Classification Product Code |
|
Date Received | 02/15/2019 |
Decision Date | 08/09/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|