DYNAGRAFT II
Filler, Bone Void, Calcium Compound
ISOTIS ORTHOBIOLOGICS, INC
The following data is part of a premarket notification filed by Isotis Orthobiologics, Inc with the FDA for Dynagraft Ii.
Pre-market Notification Details
| Device ID | K040419 |
| 510k Number | K040419 |
| Device Name: | DYNAGRAFT II |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ISOTIS ORTHOBIOLOGICS, INC PROF. BRONKHORSTLAAN 10-D P.O. BOX 98 Bilthoven, NL 3723 Mb |
| Contact | Eliane Schutte |
| Correspondent | Eliane Schutte ISOTIS ORTHOBIOLOGICS, INC PROF. BRONKHORSTLAAN 10-D P.O. BOX 98 Bilthoven, NL 3723 Mb |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-18 |
| Decision Date | 2005-03-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981153649 | K040419 | 000 |
| M3860220100501 | K040419 | 000 |
| M3860220100251 | K040419 | 000 |
| M3860220100101 | K040419 | 000 |
| M3860220001001 | K040419 | 000 |
| M3860220000501 | K040419 | 000 |
| M3860220000101 | K040419 | 000 |
| M3860220000051 | K040419 | 000 |
| M386TXG011 | K040419 | 000 |
| M386TXP101 | K040419 | 000 |
| M386TXP051 | K040419 | 000 |
| M386TXG101 | K040419 | 000 |
| M3860220101001 | K040419 | 000 |
| M386562000101 | K040419 | 000 |
| M386562000501 | K040419 | 000 |
| 10889981153632 | K040419 | 000 |
| 10889981153625 | K040419 | 000 |
| 10889981153618 | K040419 | 000 |
| 10889981153601 | K040419 | 000 |
| 10889981153595 | K040419 | 000 |
| 10889981153588 | K040419 | 000 |
| M386562101001 | K040419 | 000 |
| M386562100501 | K040419 | 000 |
| M386562100251 | K040419 | 000 |
| M386562100101 | K040419 | 000 |
| M386562001001 | K040419 | 000 |
| M386TXG051 | K040419 | 000 |
Trademark Results [DYNAGRAFT II]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DYNAGRAFT II 76427651 not registered Dead/Abandoned |
GenSci OrthoBiologics, Inc. 2002-07-05 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.