The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Progenix.
Device ID | K082463 |
510k Number | K082463 |
Device Name: | PROGENIX |
Classification | Bone Grafting Material, Human Source |
Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
Contact | Ryan Massey |
Correspondent | Ryan Massey MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
Product Code | NUN |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2008-08-27 |
Decision Date | 2008-11-10 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PROGENIX 98463197 not registered Live/Pending |
Hunt, Christian 2024-03-22 |
PROGENIX 87007945 not registered Dead/Abandoned |
Concept Laboratories, Inc. 2016-04-20 |
PROGENIX 78199350 not registered Dead/Abandoned |
Medtronic, Inc. 2003-01-02 |
PROGENIX 77081784 3373649 Live/Registered |
Warsaw Orthopedic, Inc. 2007-01-12 |
PROGENIX 75142407 not registered Dead/Abandoned |
OSIRIS THERAPEUTICS, INC. 1996-07-30 |
PROGENIX 74583361 not registered Dead/Abandoned |
PROGENIX CORPORATION 1994-10-07 |