KIJ · Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
General, Plastic Surgery · 21 CFR 878.4820 · Class 1
Overview
| Product Code | KIJ |
|---|---|
| Device Name | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment |
| Regulation | 21 CFR 878.4820 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
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 § 878.9.
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K163308 | SMARTO | Jeil Medical Corporation | Dec 27, 2016 | SESE |
| K112599 | INSURGICAL SINGLE USE POWER EQUIPMENT | Insurgical, LLC | Nov 6, 2012 | SESE |
| K101563 | SMARTO | Jeil Medical Corporation | Dec 17, 2010 | SESE |
| K972367 | STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT | Stryker Instruments | Sep 4, 1997 | SESE |
| K970378 | STRYKER 2115 REPLACEMENT BATTERY (2115) | Implant Resource, Inc. | Apr 30, 1997 | SESE |
| K960711 | ACUMED BONE GRAFT SYSTEM | Acu Med, Inc. | May 7, 1996 | SESE |
| K951450 | SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY | Strenumed, Inc. | May 17, 1995 | SESE |
| K944488 | S & S ORTHOPEDIC WIRE DRIVER 701 | S & S Orthopedic , Ltd. | Mar 2, 1995 | SESE |
| K941285 | ARTHREX GRAFT HARVESTING KIT | Arthrex, Inc. | Nov 14, 1994 | SESE |
| K933101 | THE OSTEOMED B POWER SYSTEM AND ACCESSORIES | Osteomed Corp. | Nov 7, 1994 | SESE |
| K933337 | R AND D BATTERY REPLACEMENT | R & D Batteries, Inc. | Apr 5, 1994 | SESE |
| K931395 | SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM | Micro Surgical Instruments Corp. | Jan 28, 1994 | SESE |
| K932307 | 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM | 3M Health Care, Ltd. | Jan 7, 1994 | SESE |
| K884839 | MODIFIED SAW BLADES TO THE SAGITAL SAW | Dyonics, Inc. | Dec 7, 1988 | SESE |
| K873766 | STERNAL POWER AWL | Bowen & Company, Inc. | Nov 14, 1988 | SESE |
| K864137 | LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III | Bio-Rad | Nov 7, 1986 | SESE |
| K850789 | FLUTED SUCTION MENISCAL CUTTER | T. Korossurgical Instruments Corp. | Jun 28, 1985 | SESE |
| K844163 | EZ 502 | Aeg Power Tool Corp. | Mar 11, 1985 | SESE |
| K844162 | EZ 505 | Aeg Power Tool Corp. | Mar 11, 1985 | SESE |
| K822790 | MICRO-CRAFT OSCILLATING SAW HANDPIECE | Xomed, Inc. | Oct 22, 1982 | SESE |
Top Applicants
- Black & Decker(Tm) — 5 clearances
- Dyonics, Inc. — 3 clearances
- Aeg Power Tool Corp. — 2 clearances
- Jeil Medical Corporation — 2 clearances
- 3M Health Care, Ltd. — 1 clearance
