Product code ITM
- Device name
- Cage, Knee
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3475
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832742 | EXTENSION CONTROL KNEE ORTHOSIS | Orthomedics | 1983-09-20 |
| K812064 | POLI-AXIAL KNEE CAGE | Generation II Orthotics, Inc. | 1981-08-13 |
| K770899 | FRACTURE CAST BRACE, POLY | Chase Mfg. Co. | 1977-07-21 |
| K770900 | CAST BRWM, FRACTURE | Chase Mfg. Co. | 1977-07-21 |
| K760573 | IMPROVED KNEE DRESSING | Richard'S Medical Equip., Inc. | 1976-10-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04823097722657 | "TM ""Rehabilitimed"" TUTOR-6K XSp Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097723241 | "TM ""Rehabilitimed"" TUTOR-3N UNI-3 Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097723234 | "TM ""Rehabilitimed"" TUTOR-3N UNI-2 Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097723227 | "TM ""Rehabilitimed"" TUTOR-3N UNI-1 Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097723210 | "TM ""Rehabilitimed"" TUTOR-3N UNIp-3 Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097723203 | "TM ""Rehabilitimed"" TUTOR-3N UNIp-3 Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097723159 | "TM ""Rehabilitimed"" TUTOR-N XL Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097723142 | "TM ""Rehabilitimed"" TUTOR-N L Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097723135 | "TM ""Rehabilitimed"" TUTOR-N M Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097723128 | "TM ""Rehabilitimed"" TUTOR-N S Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097723111 | "TM ""Rehabilitimed"" TUTOR-N Mp Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097723104 | "TM ""Rehabilitimed"" TUTOR-N Sp Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097723098 | "TM ""Rehabilitimed"" TUTOR-N Mp Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097723081 | "TM ""Rehabilitimed"" TUTOR-N Sp Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097722817 | "TM ""Rehabilitimed"" TUTOR-7K UNI Left Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097722800 | "TM ""Rehabilitimed"" TUTOR-7K UNI Right Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097722770 | "TM ""Rehabilitimed"" TUTOR-6K-V XL Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097722763 | "TM ""Rehabilitimed"" TUTOR-6K-V L Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097722756 | "TM ""Rehabilitimed"" TUTOR-6K-V M Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097722749 | "TM ""Rehabilitimed"" TUTOR-6K-V S Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097722732 | "TM ""Rehabilitimed"" TUTOR-6K XL Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097722725 | "TM ""Rehabilitimed"" TUTOR-6K L Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097722718 | "TM ""Rehabilitimed"" TUTOR-6K M Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097722701 | "TM ""Rehabilitimed"" TUTOR-6K S Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097722695 | "TM ""Rehabilitimed"" TUTOR-6K Sp Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097722688 | "TM ""Rehabilitimed"" TUTOR-6K XSp Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097722671 | "TM ""Rehabilitimed"" TUTOR-6K S Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097722664 | "TM ""Rehabilitimed"" TUTOR-6K Sp Comfort" | REABILITIMED TOV | 2025-05-17 |
| 04823097706022 | "TM ""Rehabilitimed"" K-1PS M" | REABILITIMED TOV | 2025-05-04 |
| 00854682001950 | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC | 2020-12-01 |