| Primary Device ID | 28031497000590 |
| NIH Device Record Key | d06f7d49-6581-499e-9d75-77b58b9f93f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InterSpace Knee |
| Version Model Number | SPK0122 |
| Company DUNS | 435428396 |
| Company Name | TECRES SPA |
| 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 | true |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 28031497000590 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/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 | 2015-10-08 |
| 28031497001160 | Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully formed gentamicin/po |
| 28031497000606 | Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully formed gentamicin/po |
| 28031497000590 | Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully formed gentamicin/po |
| 28031497000583 | Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully formed gentamicin/po |