LYS · Bone Mill
Orthopedic · 21 CFR 888.4540 · Class 1
Overview
| Product Code | LYS |
|---|---|
| Device Name | Bone Mill |
| 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.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K883183 | TRACER BONE MILL | De Medica Mfg., Inc. | Oct 12, 1988 | SESE |
| K860356 | ORTHOBLEND POWERED BONE MILL | Zimmer, Inc. | Jul 8, 1986 | SESE |
| K861164 | OSTEOMILL BONE GRINDER | Biodynamic Technologies, Inc. | May 2, 1986 | SESE |
| K860016 | AESCULAP BONE MILL | Aesculap Instruments Corp. | Mar 19, 1986 | SESE |
Top Applicants
- Zimmer, Inc. — 1 clearance
- De Medica Mfg., Inc. — 1 clearance
- Biodynamic Technologies, Inc. — 1 clearance
- Aesculap Instruments Corp. — 1 clearance
