Product code IOZ
- Device name
- Splint, Abduction, Congenital Hip Dislocation
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3665
- 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| H93350840250 | Span-America | SPAN-AMERICA MEDICAL SYSTEMS, INC. | 2023-06-08 |
| H93350840100 | Span-America | SPAN-AMERICA MEDICAL SYSTEMS, INC. | 2023-06-08 |
| H93350840110 | Span-America | SPAN-AMERICA MEDICAL SYSTEMS, INC. | 2023-06-08 |
| H93350840120 | Span-America | SPAN-AMERICA MEDICAL SYSTEMS, INC. | 2023-06-08 |
| H93350840210 | Span-America | SPAN-AMERICA MEDICAL SYSTEMS, INC. | 2023-06-08 |
| H93350840245 | Span-America | SPAN-AMERICA MEDICAL SYSTEMS, INC. | 2023-06-08 |
| H93300267100100 | Span-America | SPAN-AMERICA MEDICAL SYSTEMS, INC. | 2023-06-07 |
| H93300267100200 | Span-America | SPAN-AMERICA MEDICAL SYSTEMS, INC. | 2023-06-07 |
| H93300267100300 | Span-America | SPAN-AMERICA MEDICAL SYSTEMS, INC. | 2023-06-07 |
| H93300267500000 | Span-America | SPAN-AMERICA MEDICAL SYSTEMS, INC. | 2023-06-07 |
| 00645517328003 | Trulife | TRULIFE LIMITED | 2022-12-31 |
| 00645517327990 | Trulife | TRULIFE LIMITED | 2022-12-31 |
| 00645517327983 | Trulife | TRULIFE LIMITED | 2022-12-31 |
| G088DSHKOS0 | Panacea | Blake Manufacturing, Inc. | 2022-09-06 |
| G088DSHKOR0 | Panacea | Blake Manufacturing, Inc. | 2022-09-06 |
| G088HKOR0 | BMI | Blake Manufacturing, Inc. | 2022-08-15 |
| G088HKOS0 | BMI | Blake Manufacturing, Inc. | 2022-08-15 |
| 00749756018029 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2021-07-29 |
| 00749756018036 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2021-07-29 |
| 00749756018043 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2021-07-29 |
| 00889024369207 | N/A | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | 2020-12-15 |
| 00889024369214 | N/A | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | 2020-12-15 |
| 00889024369221 | N/A | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | 2020-12-15 |
| 00696588006116 | Universal Abduction Pillow | Innovative Medical Products, Inc | 2020-06-02 |
| 00696588005485 | Pediatric Abduction Pillow | Innovative Medical Products, Inc | 2020-06-02 |
| 00696588005447 | Slimline™ Abduction Pillow | Innovative Medical Products, Inc | 2020-06-02 |
| 00696588003818 | Universal Abduction Pillow | Innovative Medical Products, Inc | 2020-06-02 |
| 00696588003795 | Pediatric Abduction Pillow | Innovative Medical Products, Inc | 2020-06-02 |
| 00696588003597 | Slimline™ Abduction Pillow | Innovative Medical Products, Inc | 2020-06-02 |
| 00696588003580 | Slimline™ Abduction Pillow | Innovative Medical Products, Inc | 2020-06-02 |