Product code ITS
- Device name
- Joint, Hip, External Brace
- 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 |
|---|---|---|---|
| K780891 | POST-OPERATIVE HIP ORTHOSIS | Hosmer Dorrance Corp. | 1978-06-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
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| 00810178884759 | CoreTech | VIVE HEALTH LLC | 2026-04-27 |
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| 00810060887394 | Rhino | MD ORTHOPAEDICS, INC. | 2024-10-29 |
| 00810060887400 | Rhino | MD ORTHOPAEDICS, INC. | 2024-10-29 |
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| 00810060887332 | Rhino | MD ORTHOPAEDICS, INC. | 2024-01-09 |