SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP
Device Facts
| Record ID | K870842 |
|---|---|
| Device Name | SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP |
| Applicant | Warsaw Orthopedic, Inc. |
| Product Code | HTP · Orthopedic |
| Decision Date | May 27, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.4540 |
| Device Class | Class 1 |
Regulatory Classification
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.
