The following data is part of a premarket notification filed by Ossio Ltd. with the FDA for Ossiofiber Suture Anchor.
| Device ID | K213415 |
| 510k Number | K213415 |
| Device Name: | OSSIOfiber Suture Anchor |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | OSSIO Ltd. 8 HaTochen St. Caesarea, IL 3079861 |
| Contact | Taly Lindner |
| Correspondent | David McGurl MCRA, Llc 803 7th Street NW Washington, DC 20001 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-19 |
| Decision Date | 2022-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017630649 | K213415 | 000 |
| 07290017630632 | K213415 | 000 |
| 07290017630625 | K213415 | 000 |
| 07290017630618 | K213415 | 000 |
| 07290017630601 | K213415 | 000 |
| 07290017630946 | K213415 | 000 |