The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Magnifuse Bone Graft, Magifuse Ii Bone Graft.
Device ID | K131673 |
510k Number | K131673 |
Device Name: | MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
Contact | Kelly Anglin |
Correspondent | Kelly Anglin MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-07 |
Decision Date | 2013-10-03 |
Summary: | summary |