The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Plexur M.
Device ID | K081227 |
510k Number | K081227 |
Device Name: | PLEXUR M |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
Contact | Chris Talbot |
Correspondent | Chris Talbot OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-04-30 |
Decision Date | 2008-07-22 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PLEXUR M 98445222 not registered Live/Pending |
McCall International Medical Limited Partnership 2024-03-12 |
PLEXUR M 77294132 3680435 Dead/Cancelled |
Osteotech, Inc. 2007-10-02 |
PLEXUR M 77294094 3683687 Dead/Cancelled |
Osteotech, Inc. 2007-10-02 |