Splint, Extremity, Noninflatable, External, Sterile
A sterile noninflatable external extremity splint is a rigid or semi-rigid support device applied externally to an injured limb to immobilize and protect fractures, dislocations, or soft tissue injuries, supplied in a sterile condition. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FYH, regulated under 21 CFR 878.3910, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- FYH
- Device Class
- FDA class 1
- Regulation Number
- 878.3910
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K925145 | TRACE MODEL #'S 840, 841, 842, 845 | May 19, 1993 | Substantially Equivalent | Trace Medical Equipment, Inc. |
| K924984 | SPECIALIST(R) WALKER | Feb 01, 1993 | Substantially Equivalent | Johnson & Johnson Orthopaedics, Inc. |
| K895092 | KUT-SHIELD | Sep 26, 1989 | Substantially Equivalent | Kut-Guard, Inc. |
| K852558 | SPLINTS(ALL TYPE) | Jul 02, 1985 | Substantially Equivalent | The Huxley Instrument Corp. |
| K843400 | HYDRO-SPLINT A SPONGE-COMPRESS DRESS | Oct 24, 1984 | Substantially Equivalent | Compression Splint Products, Inc. |
| K821693 | J & J DIP WATER ADDITIVE | Jul 02, 1982 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |
| K802522 | DELTA-LITE CASTING TAPE & SPLINTS | Jan 08, 1981 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |
| K801436 | ORTHOPEDIC LOWER EXTREMITY SUSPENSION | Jun 26, 1980 | Substantially Equivalent | Orthopedic Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 36 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 36 registration numbers. Click on an entry to view related FDA registrations.