The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Progenix Dmb Putty.
Device ID | K072265 |
510k Number | K072265 |
Device Name: | PROGENIX DMB PUTTY |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
Contact | Christine Scifert |
Correspondent | Christine Scifert MEDTRONIC SOFAMOR DANEK 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 | 2007-08-15 |
Decision Date | 2008-01-09 |
Summary: | summary |