HTP · File
Orthopedic · 21 CFR 888.4540 · Class 1
Overview
| Product Code | HTP |
|---|---|
| Device Name | File |
| Regulation | 21 CFR 888.4540 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
Identification
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
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.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K931733 | INTERMEDICS ORTHOPEDICS REAMERS | Intermedics Orthopedics | Jan 26, 1994 | SESE |
| K870842 | SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP | Warsaw Orthopedic, Inc. | May 27, 1987 | SESE |
| K862659 | CONCEPT ARTHROSCOPY RASP | Concept, Inc. | Sep 2, 1986 | SESE |
| K841981 | 4MM & 5MM FILE | Stainless Mfg., Inc. | Jun 19, 1984 | SESE |
| K840492 | SUN-LITE BLUE SLIT | Suncoast Medical Manufacturers, Inc. | May 9, 1984 | SESE |
Top Applicants
- Warsaw Orthopedic, Inc. — 1 clearance
- Suncoast Medical Manufacturers, Inc. — 1 clearance
- Stainless Mfg., Inc. — 1 clearance
- Intermedics Orthopedics — 1 clearance
- Concept, Inc. — 1 clearance
