OSSIOfiber™ Compression Screws
Screw, Fixation, Bone
Ossio Ltd.
The following data is part of a premarket notification filed by Ossio Ltd. with the FDA for Ossiofiber™ Compression Screws.
Pre-market Notification Details
| Device ID | K193660 |
| 510k Number | K193660 |
| Device Name: | OSSIOfiber™ Compression Screws |
| Classification | Screw, Fixation, Bone |
| Applicant | Ossio Ltd. 8 HaTochen St. Caesarea, IL 3079861 |
| Contact | Taly Lindner |
| Correspondent | David Mcgurl MCRA, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-30 |
| Decision Date | 2020-07-30 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017630281 | K193660 | 000 |
| 07290017630410 | K193660 | 000 |
| 07290017630328 | K193660 | 000 |
| 07290017630335 | K193660 | 000 |
| 07290017630342 | K193660 | 000 |
| 07290017630359 | K193660 | 000 |
| 07290017630366 | K193660 | 000 |
| 07290017630373 | K193660 | 000 |
| 07290017630380 | K193660 | 000 |
| 07290017630397 | K193660 | 000 |
| 07290017630182 | K193660 | 000 |
| 07290017630199 | K193660 | 000 |
| 07290017630205 | K193660 | 000 |
| 07290017630212 | K193660 | 000 |
| 07290017630229 | K193660 | 000 |
| 07290017630236 | K193660 | 000 |
| 07290017630243 | K193660 | 000 |
| 07290017630403 | K193660 | 000 |
Trademark Results [OSSIOfiber]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSIOFIBER 79255262 not registered Live/Pending |
OSSIO LTD 2018-11-29 |
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