OSSIO™ Pin Product Family
Pin, Fixation, Smooth
Ossio Ltd.
The following data is part of a premarket notification filed by Ossio Ltd. with the FDA for Ossio™ Pin Product Family.
Pre-market Notification Details
| Device ID | K181180 |
| 510k Number | K181180 |
| Device Name: | OSSIO™ Pin Product Family |
| Classification | Pin, Fixation, Smooth |
| Applicant | Ossio Ltd. 8 HaTochen St. Caesarea, IL 3088900 |
| Contact | Taly Lindner |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street Floor 23 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 | 2018-05-02 |
| Decision Date | 2019-01-10 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017630007 | K181180 | 000 |
Trademark Results [OSSIO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSIO 88021850 5921948 Live/Registered |
Ossio LTD 2018-06-30 |
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