The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Mako Total Knee Application.
| Device ID | K220459 |
| 510k Number | K220459 |
| Device Name: | Mako Total Knee Application |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Mako Surgical Corp. 3365 Enterprise Ave. Weston, FL 33331 |
| Contact | Emily Dimambro |
| Correspondent | Emily Dimambro Mako Surgical Corp. 3365 Enterprise Ave. Weston, FL 33331 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-17 |
| Decision Date | 2022-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848486022747 | K220459 | 000 |
| 07613327600070 | K220459 | 000 |
| 07613327600063 | K220459 | 000 |