| Primary Device ID | 00848486002596 |
| NIH Device Record Key | 581d86c8-9527-4182-8069-9b1ba2353a9e |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 110165 |
| Catalog Number | 110165 |
| Company DUNS | 175239677 |
| Company Name | MAKO SURGICAL CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848486002596 [Primary] |
| OLO | Orthopedic stereotaxic instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00848486002596]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2018-10-05 |
| Device Publish Date | 2016-09-24 |
| 07613327599985 - Mako | 2023-07-31 |
| 07613327600001 - Mako | 2023-07-31 |
| 07613327600063 - Mako | 2023-07-31 |
| 07613327600070 - Mako | 2023-07-31 |
| 07613327601008 - Mako | 2023-07-31 |
| 00848486022747 - Calibration End Effector Inverted | 2022-10-13 Calibration End Effector Inverted |
| 07613327395341 - Mako | 2021-04-07 |
| 07613327395280 - NA | 2020-12-23 |