OSSE-LIGN
Cerclage, Fixation
OSSEUS, LLC
The following data is part of a premarket notification filed by Osseus, Llc with the FDA for Osse-lign.
Pre-market Notification Details
| Device ID | K023564 |
| 510k Number | K023564 |
| Device Name: | OSSE-LIGN |
| Classification | Cerclage, Fixation |
| Applicant | OSSEUS, LLC 34 WOODLANE RD. Lawrenceville, NJ 08648 |
| Contact | Shawn T Huxel |
| Correspondent | Shawn T Huxel OSSEUS, LLC 34 WOODLANE RD. Lawrenceville, NJ 08648 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-23 |
| Decision Date | 2003-03-11 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902221069S0 | K023564 | 000 |
| H67902221054S0 | K023564 | 000 |
| H67902221056S0 | K023564 | 000 |
| H67902221060S0 | K023564 | 000 |
| H67902221062S0 | K023564 | 000 |
| H67902221063S0 | K023564 | 000 |
| H67902221064S0 | K023564 | 000 |
| H67902221065S0 | K023564 | 000 |
| H67902221066S0 | K023564 | 000 |
| H67902221050S0 | K023564 | 000 |
Trademark Results [OSSE-LIGN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSE-LIGN 87808956 not registered Live/Pending |
Depuy Synthes, Inc. 2018-02-23 |
 OSSE-LIGN 86404404 not registered Dead/Abandoned |
Depuy Synthes, Inc. 2014-09-24 |
 OSSE-LIGN 85148250 not registered Dead/Abandoned |
DEPUY SYNTHES, INC. 2010-10-08 |
 OSSE-LIGN 76497963 2831574 Dead/Cancelled |
Osseus, LLC 2003-03-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.