The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Voyager Linux With Tactile Guidance System (tgs).
| Device ID | K052851 |
| 510k Number | K052851 |
| Device Name: | VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS) |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MAKO SURGICAL CORP. 2901 SIMMS STREET Hollywood, FL 33020 |
| Contact | William F Tapia |
| Correspondent | William F Tapia MAKO SURGICAL CORP. 2901 SIMMS STREET Hollywood, FL 33020 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-11 |
| Decision Date | 2005-11-18 |
| Summary: | summary |