Product Code: HSZ FDA class 1 21 CFR 878.4820

Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

General, Plastic Surgery

A pneumatic-powered orthopedic surgical instrument and accessory/attachment is a pneumatically driven tool used in orthopedic surgery for tasks such as drilling, reaming, sawing, or driving implants, along with its associated accessories. It is classified as an FDA Class 1 device under 21 CFR 878.4820, indicating low risk and general controls only. Product code HSZ falls under the General and Plastic Surgery medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

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

Device Characteristics

✗

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 56 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K991588	EMS SWISS ORTHOCLAST	Jul 21, 1999	Substantially Equivalent	(Ems Sa) Electro Medical Systems
K972860	CURVTEK TSR SYSTEM	Oct 31, 1997	Substantially Equivalent	Biolectron, Inc.
K970345	ALIGNMENT INSTRUMENT	Apr 29, 1997	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K955084	ASPACH 65,000 (MODIFICATION)	Jan 17, 1996	Substantially Equivalent	The Anspach Effort, Inc.
K954080	SODEM HIGH SPEED SYSTEM	Oct 16, 1995	Substantially Equivalent	Sodem Diffusion SA
K944590	ETHICON DRILL BIT AND DRILL GUIDE	May 11, 1995	Substantially Equivalent	ETHICON, Inc.
K934336	SPINALPLANE	Mar 10, 1995	Substantially Equivalent for Some Indications	Synvasive Technology, Inc.
K940276	FILTER, DIFFUSER	Nov 16, 1994	Substantially Equivalent	Anspach Mfg., Inc.
K942760	PNEUMATIC WIRE TENSIONER	Sep 06, 1994	Substantially Equivalent	Smith & Nephew Richards, Inc.
K941681	ARTHREX CIRCULAR HARVESTING SAW	Aug 25, 1994	Substantially Equivalent	Arthrex, Inc.
K935367	TAVA WIRE-DRIVER	Apr 21, 1994	Substantially Equivalent	Tava Surgical Instruments
K934431	PNEUMATIC WIRE TENSIONER	Jan 27, 1994	Substantially Equivalent	Smith & Nephew Richards, Inc.
K930785	THE DE SOUTTER M182 DRILL	Oct 27, 1993	Substantially Equivalent	De Soutter Medical, Ltd.
K930784	THE DE SOUTTER M193 REAMER	Oct 27, 1993	Substantially Equivalent	De Soutter Medical, Ltd.
K926547	MEDNEXT 1000 BONE DISSECTING SYSTEM	Jul 22, 1993	Substantially Equivalent	Mednext, Inc.
K922661	HHI PNEUMATIC ROTARY DRILL	Sep 18, 1992	Substantially Equivalent	H&H Instruments
K915139	MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE	Feb 05, 1992	Substantially Equivalent	Micro Surgical Instruments Corp.
K914845	M170 PNEUMATICALLY OPERATED OSCILLATING SAW	Jan 13, 1992	Substantially Equivalent	Desutter Medical , Ltd.
K913629	JOHNSON AND JOHNSON POWER SYSTEM	Nov 13, 1991	Substantially Equivalent	Johnson & Johnson Orthopaedics, Inc.
K913559	OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR	Nov 07, 1991	Substantially Equivalent	Osteo AG
K905027	CUP OUT	Feb 05, 1991	Substantially Equivalent	Anspach Mfg., Inc.
K905277	MICRO-AIRE 4220-000 OSCILLATING SAW	Jan 08, 1991	Substantially Equivalent	Micro Surgical Instruments Corp.
K905187	BONE RASPS	Dec 19, 1990	Substantially Equivalent	Micro Surgical Instruments Corp.
K904949	A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS	Nov 26, 1990	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K903713	OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229	Sep 14, 1990	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K901455	THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM	May 14, 1990	Substantially Equivalent	Kirschner Medical Corp.
K900210	BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500	Feb 02, 1990	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K885229	MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS	Sep 29, 1989	Substantially Equivalent	Romano Surgical Instrumentation, Inc.
K895121	INTERMEDICS POWER BROACH IMPACTOR	Sep 11, 1989	Substantially Equivalent	Intermedics Orthopedics
K885273	MICRO SURGICAL INSTRUMENT SYSTEM	Jan 30, 1989	Substantially Equivalent	Tava Surgical Instruments
K884492	MICRO SURGICAL INSTRUMENT SYSTEM	Nov 16, 1988	Substantially Equivalent	Tava Surgical Instruments
K881954	CONCEPT POWER SYSTEM	Nov 09, 1988	Substantially Equivalent	Concept, Inc.
K880881	ARTUS DISPOSABLE SHEATHS/CUTTERS	May 04, 1988	Substantially Equivalent	Acufex Microsurgical, Inc.
K881250	ACE PNEUMATIC OSCILLATING SAW	Apr 15, 1988	Substantially Equivalent	Buckman Co., Inc.
K880074	RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS	Mar 25, 1988	Substantially Equivalent	Romano Surgical Instrumentation, Inc.
K880324	MICRO-AIRE CEMENT REMOVAL TOOLS	Feb 17, 1988	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K872550	1.1 COUPLERS AND 1.2 ADAPTERS	Jul 21, 1987	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K871891	KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER	Jun 05, 1987	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K871287	ORTHOPEDIC DRILL GUIDE	Apr 15, 1987	Substantially Equivalent	Orthopedic Systems, Inc.
K864314	EFTEKHAR RECHANNELIZATION DRILL GUIDE	Nov 19, 1986	Substantially Equivalent	The Anspach Effort, Inc.
K861405	REPLACEMENT HOSES	Apr 25, 1986	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K851443	MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER	May 03, 1985	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K844130	ACUFEX ARTHROSCOPIC SHAVER	Mar 21, 1985	Substantially Equivalent	Acufex Microsurgical, Inc.
K844131	NUCLEOTOME	Nov 29, 1984	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K840831	ENDOTOME PNEUMATIC ORTHOPAEDIC CUT	Apr 04, 1984	Substantially Equivalent	Cabot Medical Corp.
K831756	ANSPACH 65,000	Sep 29, 1983	Substantially Equivalent	The Anspach Effort, Inc.
K811834	MICRO OSCILLATING SAW	Jul 20, 1981	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K811005	CORB TM COUNTERROTATING BIOPSY NEEDLE	Jun 15, 1981	Substantially Equivalent	Zimmer, Inc.
K803284	OSTEO OSCILAIR	Jan 09, 1981	Substantially Equivalent	Richard'S Medical Equip., Inc.
K801329	ANSPACH INSTRUMENT CADDY	Jun 09, 1980	Substantially Equivalent	The Anspach Effort, Inc.
K800275	CEBOTOME DRILL	Feb 19, 1980	Substantially Equivalent	American Sterilizer Co.
K791056	3M CEMENT REMOVER	Jul 30, 1979	Substantially Equivalent	3M Company
K790645	ENDOTOME	Apr 23, 1979	Substantially Equivalent	Berkeley Bio-Engineering
K781979	SURGAIRTOME TWO	Dec 20, 1978	Substantially Equivalent	American Sterilizer Co.
K780139	PNEUMATIC POWERED BUR	Feb 01, 1978	Substantially Equivalent	North Palm Beach Orthodepic Assoc.
K772324	WIREDRIVER	Jan 03, 1978	Substantially Equivalent	American Sterilizer Co.