| Primary Device ID | 30848486016822 |
| NIH Device Record Key | d8da908e-4fd9-4821-8ab3-44b8544278e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 111619 |
| Catalog Number | 111619 |
| Company DUNS | 175239677 |
| Company Name | MAKO SURGICAL CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848486016821 [Primary] |
| GS1 | 30848486016822 [Package] Contains: 00848486016821 Package: pack [10 Units] In Commercial Distribution |
| GAD | RETRACTOR |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-09-10 |
| Device Publish Date | 2016-09-24 |
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| 07613327627565 - Mako | 2024-11-26 MICS SAGITTAL BLADE, STANDARD |
| 07613327627572 - Mako | 2024-11-26 Blade-Narrow |
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| 07613327627213 - Mako | 2024-11-25 Mako Shoulder Burr |
| 07613327625868 - INSTRUMENT | 2024-10-14 Spine Pedicle End Effector |
| 07613327625875 - INSTRUMENT | 2024-10-14 Spine Pedicle Registration Tool |