The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Mako Surgical Tactile Guidance System Version 2.0.
| Device ID | K081867 |
| 510k Number | K081867 |
| Device Name: | MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MAKO SURGICAL CORP. 2555 DAVIE RD. Fort Lauderdale, FL 33317 |
| Contact | William Tapia |
| Correspondent | William Tapia MAKO SURGICAL CORP. 2555 DAVIE RD. Fort Lauderdale, FL 33317 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-01 |
| Decision Date | 2008-11-25 |
| Summary: | summary |