| Primary Device ID | M572TCR030066N011 |
| NIH Device Record Key | 773a51e0-413d-452c-b9ab-c09962316eb5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CR TIBIAL INSERT TRIAL SIZE 6 NARROW 6MM LEFT AND RIGHT |
| Version Model Number | TCR030066N01 |
| Catalog Number | TCR-030-066N |
| Company DUNS | 808821883 |
| Company Name | Conformis, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M572TCR030066N011 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-18 |
| Device Publish Date | 2021-06-10 |
| M572TCR000D00F021 - Identity Imprint CR Knee Replacement System | 2024-07-04 CR FEMORAL INSTRUMENTS,ALL SIZES LEFT AND RIGHT |
| M572TCR000D00T021 - Identity Imprint CR Knee Replacement System | 2024-07-04 CR TIBIAL INSTRUMENTS ALL SIZES LEFT OR RIGHT |
| M572TPS000D00F021 - Identity Imprint PS Knee Replacement System | 2024-07-04 PS Femoral INSTRUMENTS,ALL SIZES LEFT AND RIGHT |
| M572TCR302T07S011 - Identity Imprint Porous CR | 2024-02-01 IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 7 |
| 00810933031817 - Calcar Planer Adapter Drop-in | 2023-12-13 Calcar Planer Adapter Drop-in ED-09733 |
| M572POV0123208011 - Identity Imprint Porous CR | 2023-09-18 POROUS OVAL PATELLA, 32MM X 8MM, iPoly |
| M572POV0123509011 - Identity Imprint Porous CR | 2023-09-18 POROUS OVAL PATELLA, 35MM X 9MM, iPoly |
| M572POV0123809011 - Identity Imprint Porous CR | 2023-09-18 POROUS OVAL PATELLA, 38MM X 9MM, iPoly |