Product code IQF
- Device name
- Orthosis, Cervical-Thoracic, Rigid
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3490
- 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 |
|---|---|---|---|
| K832741 | JASON CERVICAL ORTHOSIS | Orthomedics | 1983-09-20 |
| K812342 | ZEE EXTRICATION DEVICE | Zee Medical Products Co., Inc. | 1981-09-21 |
| K811297 | CERVICAL SUPPORT | Orthomedics | 1981-05-27 |
| K810555 | SCOLIOSIS ORTHOTIC SYSTEM | Orthomedics | 1981-03-13 |
| K791350 | POPE AMBULATORY HALO VEST | Hospital Products Co. | 1979-08-03 |
| K781761 | KENDRICK EXTRICATION DEVICE | Medi-Ked, Inc. | 1978-10-27 |
| K780489 | SPINE BOARD | Marullo, Baldwin, Frieden, Gatewood, | 1978-04-12 |
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| 00645517898940 | Trulife | TRULIFE LIMITED | 2025-09-11 |
| 00645517899114 | Trulife | TRULIFE LIMITED | 2025-09-11 |
| 00645517510743 | Trulife | TRULIFE LIMITED | 2025-09-03 |
| 00645517024189 | Trulife | TRULIFE LIMITED | 2025-09-03 |
| 00645517323831 | Trulife | TRULIFE LIMITED | 2025-09-03 |
| 00645517323848 | Trulife | TRULIFE LIMITED | 2025-09-03 |
| 00645517323886 | Trulife | TRULIFE LIMITED | 2025-09-03 |
| 00645517323947 | Trulife | TRULIFE LIMITED | 2025-09-03 |
| 00645517510729 | Trulife | TRULIFE LIMITED | 2025-09-03 |
| 08057592700124 | NECKLITE | FLAMOR SRL | 2025-01-27 |
| 08057592700117 | NECKLITE | FLAMOR SRL | 2025-01-27 |
| 08057592700100 | NECKLITE | FLAMOR SRL | 2025-01-27 |
| 08057592700094 | NECKLITE | FLAMOR SRL | 2025-01-27 |
| 08057592700131 | NECKLITE | FLAMOR SRL | 2025-01-27 |
| 08057592700148 | NECKLITE | FLAMOR SRL | 2025-01-27 |
| 00645517024172 | Trulife | TRULIFE LIMITED | 2023-06-06 |
| 00645517326375 | Trulife | TRULIFE LIMITED | 2022-12-31 |
| 00645517322681 | Trulife | TRULIFE LIMITED | 2022-12-31 |
| 00645517322698 | Trulife | TRULIFE LIMITED | 2022-12-31 |
| 00645517325002 | Trulife | TRULIFE LIMITED | 2022-12-31 |
| 00645517326306 | Trulife | TRULIFE LIMITED | 2022-12-31 |
| 00645517326351 | Trulife | TRULIFE LIMITED | 2022-12-31 |
| 00645517322674 | Trulife | TRULIFE LIMITED | 2022-12-31 |
| 10817357022053 | Miami J | HYGIA HEALTH SERVICES, INC. | 2016-09-24 |
| 10817357022046 | Miami J | HYGIA HEALTH SERVICES, INC. | 2016-09-24 |
| 10817357021711 | Miami J | HYGIA HEALTH SERVICES, INC. | 2016-09-24 |
| 10817357021643 | Miami J | HYGIA HEALTH SERVICES, INC. | 2016-09-24 |
| 10817357021506 | Ambu | HYGIA HEALTH SERVICES, INC. | 2016-09-24 |