LGG · Instrument, Cast Application/Removal, Manual
Orthopedic · 21 CFR 888.5980 · Class 1
Overview
| Product Code | LGG |
|---|---|
| Device Name | Instrument, Cast Application/Removal, Manual |
| Regulation | 21 CFR 888.5980 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
| GMP Exempt | Yes |
Identification
A manual cast application and removal instrument is a nonpowered hand-held device intended to be used in applying or removing a cast. This generic type of device includes the cast knife, cast spreader, plaster saw, plaster dispenser, and casting stand.
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 the limitations in § 888.9. The device is also 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.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K870100 | PLASTER STAND | Orthopedic Systems, Inc. | Jan 28, 1987 | SESE |
| K851786 | 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF | Artiberia | Jul 9, 1985 | SESE |
| K834384 | MODULAR EXTREMITY CASTING SUPPORT | Buckman Co., Inc. | Jan 30, 1984 | SESE |
Top Applicants
- Orthopedic Systems, Inc. — 1 clearance
- Buckman Co., Inc. — 1 clearance
- Artiberia — 1 clearance
