| Primary Device ID | 00848486016197 |
| NIH Device Record Key | f40fbbe6-1da0-491c-8d36-5fdc2493c005 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RESTORIS PST |
| Version Model Number | 188611 |
| Catalog Number | 188611 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848486016197 [Primary] |
| HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-12-11 |
| 00848486016265 | Porous Tibial Baseplate |
| 00848486016258 | Porous Tibial Baseplate |
| 00848486016241 | Porous Tibial Baseplate |
| 00848486016234 | Porous Tibial Baseplate |
| 00848486016227 | Porous Tibial Baseplate |
| 00848486016210 | Porous Tibial Baseplate |
| 00848486016203 | Porous Tibial Baseplate |
| 00848486016197 | Porous Tibial Baseplate |
| 00848486016180 | Porous Tibial Baseplate |
| 00848486016173 | Porous Tibial Baseplate |
| 00848486016166 | Porous Tibial Baseplate |
| 00848486016159 | Porous Tibial Baseplate |
| 00848486016142 | Porous Tibial Baseplate |
| 00848486016135 | Porous Tibial Baseplate |
| 00848486016128 | Porous Tibial Baseplate |
| 00848486016111 | Porous Tibial Baseplate |
| 00848486008444 | Acetabular Shell, Cluster Hole |
| 00848486008437 | Acetabular Shell, Cluster Hole |
| 00848486008420 | Acetabular Shell, Cluster Hole |
| 00848486008413 | Acetabular Shell, Cluster Hole |
| 00848486008406 | Acetabular Shell, Cluster Hole |
| 00848486008390 | Acetabular Shell, Cluster Hole |
| 00848486008383 | Acetabular Shell, Cluster Hole |
| 00848486008376 | Acetabular Shell, Cluster Hole |
| 00848486008369 | Acetabular Shell, Cluster Hole |
| 00848486008352 | Acetabular Shell, Cluster Hole |
| 00848486008345 | Acetabular Shell, Cluster Hole |
| 00848486008338 | Acetabular Shell, Cluster Hole |
| 00848486008321 | Acetabular Shell, Cluster Hole |