The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Mako Surgical Corp Robotic Arm Interactive Orthopedic System-tha.
| Device ID | K093425 |
| 510k Number | K093425 |
| Device Name: | MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA |
| Classification | Orthopedic 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 | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-03 |
| Decision Date | 2010-02-24 |
| Summary: | summary |