The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Mako Total Hip Application.
| Device ID | K193128 |
| 510k Number | K193128 |
| Device Name: | Mako Total Hip Application |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Mako Surgical Corp. 2555 Davie Rd Fort Lauderdale, FL 33317 |
| Contact | Liza Gordillo |
| Correspondent | Liza Gordillo Mako Surgical Corp. 2555 Davie Rd Fort Lauderdale, FL 33317 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-12 |
| Decision Date | 2020-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327468311 | K193128 | 000 |
| 07613327468298 | K193128 | 000 |
| 07613327601008 | K193128 | 000 |
| 07613327600001 | K193128 | 000 |