Splint, Extremity, Noninflatable, External, Sterile
FDA product code FYH · Class I (low risk) · 21 CFR 878.3910 · General, Plastic Surgery
8510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K925145 | Trace Model #'S 840, 841, 842, 845FYH · Traditional | Trace Medical Equipment, Inc. | 05/19/1993SE |
| K924984 | Specialist(R) WalkerFYH · Traditional | Johnson & Johnson Orthopaedics, Inc. | 02/01/1993SE |
| K895092 | Kut-ShieldFYH · Traditional | Kut-Guard, Inc. | 09/26/1989SE |
| K852558 | Splints(All Type)FYH · Traditional | The Huxley Instrument Corp. | 07/02/1985SE |
| K843400 | Hydro-Splint a Sponge-Compress DressFYH · Traditional | Compression Splint Products, Inc. | 10/24/1984SE |
| K821693 | J & J Dip Water AdditiveFYH · Traditional | Johnson & Johnson Professionals, Inc. | 07/02/1982SE |
| K802522 | Delta-Lite Casting Tape & SplintsFYH · Traditional | Johnson & Johnson Professionals, Inc. | 01/08/1981SE |
| K801436 | Orthopedic Lower Extremity SuspensionFYH · Traditional | Orthopedic Systems, Inc. | 06/26/1980SE |