OSSIOfiber® Staple
Staple, Absorbable
OSSIO Ltd.
The following data is part of a premarket notification filed by Ossio Ltd. with the FDA for Ossiofiber® Staple.
Pre-market Notification Details
| Device ID | K212594 |
| 510k Number | K212594 |
| Device Name: | OSSIOfiber® Staple |
| Classification | Staple, Absorbable |
| Applicant | OSSIO Ltd. 8 HaTochen St. Caesarea, IL 3079861 |
| Contact | Taly Linder |
| Correspondent | David Mcgurl MCRA, LLC 803 7th Street NW Washington, DC 20001 |
| Product Code | MNU |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-16 |
| Decision Date | 2022-01-21 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017630885 | K212594 | 000 |
| 07290017630908 | K212594 | 000 |
| 07290017630892 | K212594 | 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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