OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
Pin, Fixation, Smooth
Ossio Ltd.
The following data is part of a premarket notification filed by Ossio Ltd. with the FDA for Ossiofiber™ Hammertoe Fixation System/ossiofiber™ Hammertoe Fixation Implant.
Pre-market Notification Details
| Device ID | K190652 |
| 510k Number | K190652 |
| Device Name: | OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant |
| Classification | Pin, Fixation, Smooth |
| Applicant | Ossio Ltd. 8 HaTochen St. Caesarea, IL 3079861 |
| Contact | Taly Lindner |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, PA 19103 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-13 |
| Decision Date | 2020-03-06 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017630120 | K190652 | 000 |
| 07290017630021 | K190652 | 000 |
| 07290017630038 | K190652 | 000 |
| 07290017630045 | K190652 | 000 |
| 07290017630052 | K190652 | 000 |
| 07290017630069 | K190652 | 000 |
| 07290017630076 | K190652 | 000 |
| 07290017630083 | K190652 | 000 |
| 07290017630090 | K190652 | 000 |
| 07290017630106 | K190652 | 000 |
| 07290017630113 | K190652 | 000 |
| 07290017630014 | K190652 | 000 |
Trademark Results [OSSIOfiber]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSIOFIBER 79255262 not registered Live/Pending |
OSSIO LTD 2018-11-29 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.