HXJ · Staple Driver
Orthopedic · 21 CFR 888.4540 · Class 1
Overview
| Product Code | HXJ |
|---|---|
| Device Name | Staple Driver |
| 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 (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964953 | IN-TAC BONE ANCHOR SYSTEM | Influence, Inc. | Feb 13, 1997 | SESE |
| K962372 | UROTAC BONE ANCHOR INSERTER | Influence, Inc. | Aug 19, 1996 | SESE |
| K930205 | ELECTRIC WIRE DRIVER, MODEL 2640E | Micro Surgical Instruments Corp. | Aug 2, 1993 | SESE |
| K834515 | FIXATION STAPLE KIT - DLIDE HAMMER | Stryker Corp. | Apr 23, 1984 | SESE |
| K830456 | STAPLE INSERTER-EXTRACTOR FOR ARTHROS | Instrument Makar, Inc. | Mar 9, 1983 | SESE |
| K830255 | OSTEOTOMY BONE STAPLE | Techmedica, Inc. | Mar 9, 1983 | SESE |
Top Applicants
- Influence, Inc. — 2 clearances
- Techmedica, Inc. — 1 clearance
- Stryker Corp. — 1 clearance
- Micro Surgical Instruments Corp. — 1 clearance
- Instrument Makar, Inc. — 1 clearance
