HXK · Holder, Needle; Orthopedic
Orthopedic · 21 CFR 888.4540 · Class 1
Overview
| Product Code | HXK |
|---|---|
| Device Name | Holder, Needle; Orthopedic |
| 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 |
|---|---|---|---|---|
| K890167 | HOLDER, NEEDLE | Dhason Brothers, Inc. | Feb 3, 1989 | SESE |
| K872989 | MICRINS NEEDLE HOLDER | Micrins Surgical, Inc. | Aug 21, 1987 | SESE |
| K860018 | FISCHER WIRE/PIN CLAMP | Buckman Co., Inc. | Feb 7, 1986 | SESE |
| K801594 | ACE FISCHER EXTERNAL FIXATION DEVICE | Ace Orthopedic Manufacturing Co. | Sep 9, 1980 | SESE |
| K772388 | CONVERSE-GILLIES NEEDLE HOLDER | Edward Weck, Inc. | Jan 20, 1978 | SESE |
Top Applicants
- Micrins Surgical, Inc. — 1 clearance
- Edward Weck, Inc. — 1 clearance
- Dhason Brothers, Inc. — 1 clearance
- Buckman Co., Inc. — 1 clearance
- Ace Orthopedic Manufacturing Co. — 1 clearance
