Product code HSP
- Device name
- Splint, Traction
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.5890
- Review panel
- OR
- 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 |
|---|---|---|---|
| K770898 | FRACTURE CAST BRACE KIT, PLASTIC | Chase Mfg. Co. | 1977-07-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
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| 06975675788888 | Rhino Rescue | EMSRUN GROUP | 2025-11-06 |
| 06975675788871 | Rhino Rescue | EMSRUN GROUP | 2025-11-06 |
| 06975675788864 | Rhino Rescue | EMSRUN GROUP | 2025-11-06 |
| 06975675788857 | Rhino Rescue | EMSRUN GROUP | 2025-10-30 |
| 06975675788208 | Rhino Rescue | EMSRUN GROUP | 2025-10-29 |
| 06975675788185 | Rhino Rescue | EMSRUN GROUP | 2025-10-29 |
| 06975675788192 | Rhino Rescue | EMSRUN GROUP | 2025-10-29 |
| 16974567745906 | RHINO RESCUE | Wuxi Emsrun Technology Co., Ltd. | 2024-05-13 |
| 06974567745909 | RHINO RESCUE | Wuxi Emsrun Technology Co., Ltd. | 2024-05-13 |
| 16974567746934 | RHINO RESCUE | Wuxi Emsrun Technology Co., Ltd. | 2023-06-28 |
| 06974567746937 | RHINO RESCUE | Wuxi Emsrun Technology Co., Ltd. | 2023-06-28 |
| 05060483570051 | Prometheus Traction Splint | SAFEGUARD MEDICAL TECHNOLOGIES LIMITED | 2023-05-01 |
| 16952534421022 | Senolo | JIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD. | 2023-04-06 |
| 16952534421039 | Senolo | JIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD. | 2023-04-06 |
| 16952534421046 | Senolo | JIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD. | 2023-04-06 |
| 16952534421053 | Senolo | JIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD. | 2023-04-06 |
| 16952534421060 | Senolo | JIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD. | 2023-04-06 |
| 16952534421114 | Senolo | JIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD. | 2023-04-06 |
| 16952534421121 | Senolo | JIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD. | 2023-04-06 |
| 16952534421138 | Senolo | JIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD. | 2023-04-06 |
| 46974567747819 | RHINO RESCUE | Wuxi Emsrun Technology Co., Ltd. | 2023-03-21 |
| 36974567747829 | RHINO RESCUE | Wuxi Emsrun Technology Co., Ltd. | 2023-03-21 |
| 36974567747812 | RHINO RESCUE | Wuxi Emsrun Technology Co., Ltd. | 2023-03-21 |
| 16974567748167 | RHINO RESCUE | Wuxi Emsrun Technology Co., Ltd. | 2023-02-20 |
| 16974567748150 | RHINO RESCUE | Wuxi Emsrun Technology Co., Ltd. | 2023-02-20 |
| 16974567748143 | RHINO RESCUE | Wuxi Emsrun Technology Co., Ltd. | 2023-02-20 |
| 16974567748136 | RHINO RESCUE | Wuxi Emsrun Technology Co., Ltd. | 2023-02-20 |
| 00609271080607 | BUCKS TRACTION w/LINER | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00889024369245 | n/a | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | 2020-09-21 |