Product Code: KIJ FDA class 1 21 CFR 878.4820

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

General, Plastic Surgery

DC-Powered Motor Orthopedic Surgical Instrument and Accessory is an electrically powered surgical tool and its associated attachments, driven by a direct current motor, used in orthopedic and surgical procedures to perform drilling, reaming, sawing, and other bone-related tasks requiring precise mechanical action. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIJ, regulated under 21 CFR 878.4820, within the General, Plastic Surgery medical specialty.

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FEI Numbers

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Basic Information

Product Code: KIJ
Device Class: FDA class 1
Regulation Number: 878.4820
Medical Specialty: General, Plastic Surgery
Review Panel: OR
Submission Type: 4

Device Characteristics

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GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 29 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K163308	SMARTO	Dec 27, 2016	Substantially Equivalent	Jeil Medical Corporation
K112599	INSURGICAL SINGLE USE POWER EQUIPMENT	Nov 06, 2012	Substantially Equivalent	Insurgical, LLC
K101563	SMARTO	Dec 17, 2010	Substantially Equivalent	Jeil Medical Corporation
K972367	STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT	Sep 04, 1997	Substantially Equivalent	Stryker Instruments
K970378	STRYKER 2115 REPLACEMENT BATTERY (2115)	Apr 30, 1997	Substantially Equivalent	Implant Resource, Inc.
K960711	ACUMED BONE GRAFT SYSTEM	May 07, 1996	Substantially Equivalent	Acu Med, Inc.
K951450	SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY	May 17, 1995	Substantially Equivalent	Strenumed, Inc.
K944488	S & S ORTHOPEDIC WIRE DRIVER 701	Mar 02, 1995	Substantially Equivalent	S & S Orthopedic , Ltd.
K941285	ARTHREX GRAFT HARVESTING KIT	Nov 14, 1994	Substantially Equivalent	Arthrex, Inc.
K933101	THE OSTEOMED B POWER SYSTEM AND ACCESSORIES	Nov 07, 1994	Substantially Equivalent	Osteomed Corp.
K933337	R AND D BATTERY REPLACEMENT	Apr 05, 1994	Substantially Equivalent	R & D Batteries, Inc.
K931395	SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM	Jan 28, 1994	Substantially Equivalent	Micro Surgical Instruments Corp.
K932307	3M MAXI-DRIVER II DBATTERY POWERED SYSTEM	Jan 07, 1994	Substantially Equivalent	3M Health Care, Ltd.
K884839	MODIFIED SAW BLADES TO THE SAGITAL SAW	Dec 07, 1988	Substantially Equivalent	Dyonics, Inc.
K873766	STERNAL POWER AWL	Nov 14, 1988	Substantially Equivalent	Bowen & Company, Inc.
K864137	LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III	Nov 07, 1986	Substantially Equivalent	Bio-Rad
K850789	FLUTED SUCTION MENISCAL CUTTER	Jun 28, 1985	Substantially Equivalent	T. Korossurgical Instruments Corp.
K844163	EZ 502	Mar 11, 1985	Substantially Equivalent	Aeg Power Tool Corp.
K844162	EZ 505	Mar 11, 1985	Substantially Equivalent	Aeg Power Tool Corp.
K822790	MICRO-CRAFT OSCILLATING SAW HANDPIECE	Oct 22, 1982	Substantially Equivalent	Xomed, Inc.
K820367	INTRA-ARTICULAR SURGICAL SYSTEM	May 07, 1982	Substantially Equivalent	Dyonics, Inc.
K800315	DUAL MPC CHARGER	Mar 19, 1980	Substantially Equivalent	Black & Decker(Tm)
K800314	POWER PACK	Mar 19, 1980	Substantially Equivalent	Black & Decker(Tm)
K800313	SAGITTAL SAW	Feb 22, 1980	Substantially Equivalent	Black & Decker(Tm)
K800312	150 DRIVER/REAMER	Feb 22, 1980	Substantially Equivalent	Black & Decker(Tm)
K800311	450 DRILL/800 DRILL	Feb 22, 1980	Substantially Equivalent	Black & Decker(Tm)
K790063	DRILL, CORDLESS SURGICAL	Feb 05, 1979	Substantially Equivalent	Richard'S Medical Equip., Inc.
K780645	HMD-2000 BATTERY-POWERED MINI-DRILL, THE	May 03, 1978	Substantially Equivalent	Medishield, Inc.
K771218	INTRA-ARTICULAR SHAVER	Feb 01, 1978	Substantially Equivalent	Dyonics, Inc.