The following data is part of a premarket notification filed by Kico Knee Innovation Company Pty Limited with the FDA for 360cas.
| Device ID | K213380 |
| 510k Number | K213380 |
| Device Name: | 360CAS |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Kico Knee Innovation Company Pty Limited Suite 3, Building 1, 20 Bridge Street Pymble, AU 2073 |
| Contact | Stefanie Auf Der Mauer |
| Correspondent | Stefanie Auf Der Mauer Kico Knee Innovation Company Pty Limited Suite 3, Building 1, 20 Bridge Street Pymble, AU 2073 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-13 |
| Decision Date | 2022-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B432360CAS2100 | K213380 | 000 |
| B432360CAS01020 | K213380 | 000 |
| B432360CAS01030 | K213380 | 000 |
| B432360CASSET00050 | K213380 | 000 |
| B432360CAS00240 | K213380 | 000 |
| B432360CAS00030 | K213380 | 000 |
| B432360CAS00390 | K213380 | 000 |
| B432360CAS01040 | K213380 | 000 |
| B432360CAS00020 | K213380 | 000 |
| B432360CAS00100 | K213380 | 000 |
| B432360CAS00130 | K213380 | 000 |
| B432360CAS00680 | K213380 | 000 |
| B432360CAS00690 | K213380 | 000 |
| B432360CAS00760 | K213380 | 000 |
| B432360CAS01000 | K213380 | 000 |
| B432360CAS00750 | K213380 | 000 |