PLEXUR P
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
OSTEOTECH, INC.
The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Plexur P.
Pre-market Notification Details
| Device ID | K061982 |
| 510k Number | K061982 |
| Device Name: | PLEXUR P |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Contact | Christopher W Talbot |
| Correspondent | Christopher W Talbot OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-13 |
| Decision Date | 2007-02-07 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994986672 | K061982 | 000 |
| 00613994986573 | K061982 | 000 |
| 00613994986580 | K061982 | 000 |
| 00613994986597 | K061982 | 000 |
| 00613994986603 | K061982 | 000 |
| 00613994986610 | K061982 | 000 |
| 00613994986627 | K061982 | 000 |
| 00613994986634 | K061982 | 000 |
| 00613994986641 | K061982 | 000 |
| 00613994986658 | K061982 | 000 |
| 00613994986665 | K061982 | 000 |
| 00613994986566 | K061982 | 000 |
Trademark Results [PLEXUR P]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLEXUR P 77294070 3444563 Dead/Cancelled |
Osteotech, Inc. 2007-10-02 |
 PLEXUR P 77294057 3444561 Dead/Cancelled |
Osteotech, Inc. 2007-10-02 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.