Product code IPT
- Device name
- Orthosis, Thoracic
- 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 |
|---|---|---|---|
| K963091 | VOLLMAN PRONE POSITIONER | Hill-Rom, Inc. | 1997-01-09 |
| K821645 | BACK SKPPORTS | Fred Sammons, Inc. | 1982-06-11 |
| K812401 | CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O | Surgical Appliance Industries, Inc. | 1981-09-14 |
| K811750 | MULTITUBULAR THORACIC AIR SPLINTS | Roger Cestac & Assoc. | 1981-07-20 |
| K761128 | LATERAL TRUNK SUPPORTS | Fred Sammons, Inc. | 1976-12-02 |
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|---|---|---|---|
| 00810178888092 | CoreTech | VIVE HEALTH LLC | 2026-05-05 |
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| 00810178888894 | CoreTech | VIVE HEALTH LLC | 2026-05-05 |
| 00810178889075 | CoreTech | VIVE HEALTH LLC | 2026-05-05 |
| 00810178889174 | CoreTech | VIVE HEALTH LLC | 2026-05-05 |
| 00810178889259 | CoreTech | VIVE HEALTH LLC | 2026-05-05 |
| 00810178889266 | CoreTech | VIVE HEALTH LLC | 2026-05-05 |
| 00850071315264 | Trend | Orthofix US LLC | 2026-04-25 |
| 00850071315271 | Trend | Orthofix US LLC | 2026-04-14 |
| 00850071315257 | Trend | Orthofix US LLC | 2026-04-14 |
| 00850071315240 | Trend | Orthofix US LLC | 2026-04-14 |
| 00810113682723 | Tailback2-64 | Manamed, Inc. | 2025-09-19 |
| 00810113682716 | Tailback2-56 | Manamed, Inc. | 2025-09-19 |
| 00860014460821 | Boston Overlap Brace (BOB) | Boston Brace International, Inc. | 2025-08-05 |
| 00860014460814 | Boston Body Jacket, Bivalve Opening | Boston Brace International, Inc. | 2025-08-05 |
| 00860014460807 | Boston Body Jacket, Single Opening | Boston Brace International, Inc. | 2025-08-05 |
| 00860010708163 | Boston Brace | Boston Brace International, Inc. | 2024-06-10 |
| 00860010708170 | Boston Brace | Boston Brace International, Inc. | 2024-06-10 |
| 00860010708187 | Boston Brace | Boston Brace International, Inc. | 2024-06-10 |
| 00860010708118 | Boston Brace | Boston Brace International, Inc. | 2024-04-30 |
| 00860010708125 | Boston Brace | Boston Brace International, Inc. | 2024-04-30 |
| 00860010708132 | Boston Brace | Boston Brace International, Inc. | 2024-04-30 |
| 00860010708149 | Boston Brace | Boston Brace International, Inc. | 2024-04-30 |
| 00860010708156 | Boston Brace | Boston Brace International, Inc. | 2024-04-30 |
| 00810113574097 | CoreTech | VIVE HEALTH LLC | 2023-10-18 |
| 00810113572734 | CoreTech | VIVE HEALTH LLC | 2023-08-07 |
| 00810105030556 | NekSpine System, w/ Medium Support | COMPOSITE MANUFACTURING, INC. | 2023-01-16 |
| 00810105030563 | NekSpine System, w/ Large Support | COMPOSITE MANUFACTURING, INC. | 2023-01-16 |
| 00810105030549 | NekSpine System, w/ Small Support | COMPOSITE MANUFACTURING, INC. | 2023-01-16 |
| 00810041982346 | CoreTech | VIVE HEALTH LLC | 2022-05-26 |