Product code FYH
- Device name
- Splint, Extremity, Noninflatable, External, Sterile
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.3910
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K925145 | TRACE MODEL #'S 840, 841, 842, 845 | Trace Medical Equipment, Inc. | 1993-05-19 |
| K924984 | SPECIALIST(R) WALKER | Johnson & Johnson Orthopaedics, Inc. | 1993-02-01 |
| K895092 | KUT-SHIELD | Kut-Guard, Inc. | 1989-09-26 |
| K852558 | SPLINTS(ALL TYPE) | The Huxley Instrument Corp. | 1985-07-02 |
| K843400 | HYDRO-SPLINT A SPONGE-COMPRESS DRESS | Compression Splint Products, Inc. | 1984-10-24 |
| K821693 | J & J DIP WATER ADDITIVE | Johnson & Johnson Professionals, Inc. | 1982-07-02 |
| K802522 | DELTA-LITE CASTING TAPE & SPLINTS | Johnson & Johnson Professionals, Inc. | 1981-01-08 |
| K801436 | ORTHOPEDIC LOWER EXTREMITY SUSPENSION | Orthopedic Systems, Inc. | 1980-06-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00026072022900 | SC | Allied Medical, LLC | 2024-05-09 |
| 00026072022894 | SC | Allied Medical, LLC | 2024-05-09 |
| 00026072022825 | SC | Allied Medical, LLC | 2024-05-09 |
| 00026072022818 | SC | Allied Medical, LLC | 2024-05-09 |
| 00026072022801 | SC | Allied Medical, LLC | 2024-05-09 |
| 00026072022795 | SC | Allied Medical, LLC | 2024-05-09 |
| 00026072022788 | SC | Allied Medical, LLC | 2024-05-09 |
| 00026072022771 | SC | Allied Medical, LLC | 2024-05-09 |
| 00026072012208 | SC | Allied Medical, LLC | 2024-05-09 |
| 00817612020964 | Dale Post Surgical Bra | Dale Medical Products, Inc. | 2024-04-25 |
| 10861887000210 | INRO Surgical Nail | Inro Medical Designs Inc | 2023-08-17 |
| 00861887000213 | INRO Surgical Nail | Inro Medical Designs Inc | 2023-08-17 |
| 00817612020995 | Dale Strapless Bendable Armboard | DALE MEDICAL PRODUCTS, INC. | 2020-09-14 |
| 00817612021015 | Dale Strapless Bendable Armboard | DALE MEDICAL PRODUCTS, INC. | 2020-09-14 |
| 00082161503118 | Nice Stretch | BROWNMED, INC. | 2020-08-17 |
| 05019315057888 | Jelco | ICU MEDICAL, INC. | 2020-05-06 |
| 15019315057878 | Jelco | ICU MEDICAL, INC. | 2020-05-05 |
| 15019315057960 | Jelco | ICU MEDICAL, INC. | 2020-03-26 |
| 15019315057953 | Jelco | ICU MEDICAL, INC. | 2020-03-26 |
| 15019315057946 | Jelco | ICU MEDICAL, INC. | 2020-03-26 |
| 15019315057939 | Jelco | ICU MEDICAL, INC. | 2020-03-26 |
| 15019315057922 | Jelco | ICU MEDICAL, INC. | 2020-03-26 |
| 00817612020322 | Dale Bendable Armboard | Dale Medical Products, Inc. | 2019-09-04 |
| 00817612020308 | Dale Bendable Armboard | Dale Medical Products, Inc. | 2019-09-04 |
| 00817612020285 | Dale Bendable Armboard | Dale Medical Products, Inc. | 2019-09-04 |
| 00817612020346 | Dale Bendable Armboard | Dale Medical Products, Inc. | 2019-02-19 |
| H84106531 | Dale Bendable Armboard | Dale Medical Products, Inc. | 2018-08-29 |
| 05019315057918 | Jelco | ICU MEDICAL, INC. | 2017-01-03 |
| 05019315057864 | Jelco | ICU MEDICAL, INC. | 2017-01-03 |
| 15019315057847 | Jelco | ICU MEDICAL, INC. | 2017-01-03 |