FYH · Splint, Extremity, Noninflatable, External, Sterile
General, Plastic Surgery · 21 CFR 878.3910 · Class 1
Overview
| Product Code | FYH |
|---|---|
| Device Name | Splint, Extremity, Noninflatable, External, Sterile |
| Regulation | 21 CFR 878.3910 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K925145 | TRACE MODEL #'S 840, 841, 842, 845 | Trace Medical Equipment, Inc. | May 19, 1993 | SESE |
| K924984 | SPECIALIST(R) WALKER | Johnson & Johnson Orthopaedics, Inc. | Feb 1, 1993 | SESE |
| K895092 | KUT-SHIELD | Kut-Guard, Inc. | Sep 26, 1989 | SESE |
| K852558 | SPLINTS(ALL TYPE) | The Huxley Instrument Corp. | Jul 2, 1985 | SESE |
| K843400 | HYDRO-SPLINT A SPONGE-COMPRESS DRESS | Compression Splint Products, Inc. | Oct 24, 1984 | SESE |
| K821693 | J & J DIP WATER ADDITIVE | Johnson & Johnson Professionals, Inc. | Jul 2, 1982 | SESE |
| K802522 | DELTA-LITE CASTING TAPE & SPLINTS | Johnson & Johnson Professionals, Inc. | Jan 8, 1981 | SESE |
| K801436 | ORTHOPEDIC LOWER EXTREMITY SUSPENSION | Orthopedic Systems, Inc. | Jun 26, 1980 | SESE |
Top Applicants
- Johnson & Johnson Professionals, Inc. — 2 clearances
- Compression Splint Products, Inc. — 1 clearance
- Johnson & Johnson Orthopaedics, Inc. — 1 clearance
- Kut-Guard, Inc. — 1 clearance
- Orthopedic Systems, Inc. — 1 clearance
