SYNPLUG
Cement Obturator
ISOTIS NV
The following data is part of a premarket notification filed by Isotis Nv with the FDA for Synplug.
Pre-market Notification Details
| Device ID | K010840 |
| 510k Number | K010840 |
| Device Name: | SYNPLUG |
| Classification | Cement Obturator |
| Applicant | ISOTIS NV 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J M. Nolte |
| Correspondent | Cynthia J M. Nolte ISOTIS NV 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-21 |
| Decision Date | 2001-04-20 |
| Summary: | summary |
Trademark Results [SYNPLUG]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNPLUG 76261221 2708533 Live/Registered |
ISOTIS ORTHOBIOLOGICS, INC. 2001-05-22 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.