The following data is part of a premarket notification filed by Ossio Ltd. with the FDA for Ossiofiber Compression Screw, 3.5mm.
| Device ID | K213596 |
| 510k Number | K213596 |
| Device Name: | OSSIOfiber Compression Screw, 3.5mm |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-12 |
| Decision Date | 2021-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017630779 | K213596 | 000 |
| 07290017630793 | K213596 | 000 |
| 07290017630809 | K213596 | 000 |
| 07290017630816 | K213596 | 000 |
| 07290017630922 | K213596 | 000 |
| 07290017630724 | K213596 | 000 |
| 07290017630731 | K213596 | 000 |
| 07290017630748 | K213596 | 000 |
| 07290017630755 | K213596 | 000 |
| 07290017630762 | K213596 | 000 |
| 07290017630786 | K213596 | 000 |