Product Code: HTZ FDA class 1 21 CFR 878.4800

Instrument, Cutting, Orthopedic

General, Plastic Surgery

An orthopedic cutting instrument is a surgical tool designed specifically for cutting tissue or bone during orthopedic procedures, encompassing instruments used in general and plastic surgery contexts. It is classified as an FDA Class 1 device under 21 CFR 878.4800, indicating low risk and general controls only. Product code HTZ falls under the General and Plastic Surgery medical specialty.

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510(k)s

FEI Numbers

230

Registration Numbers

230

Unique Applicants

Years Active

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Basic Information

Product Code: HTZ
Device Class: FDA class 1
Regulation Number: 878.4800
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 21 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K933933	CEBOPLANE	Apr 15, 1994	Substantially Equivalent	Synvasive Technology, Inc.
K931737	HEDLEYL INTRAMEDULLARY PREPARATION BRUSH	Jan 07, 1994	Substantially Equivalent	Synvasive Technology, Inc.
K870882	45 DEGREE SHAVER	Mar 23, 1987	Substantially Equivalent	Bowen & Company, Inc.
K853678	KAMBIN SPINAL INSTRUMENT SET	Sep 24, 1985	Substantially Equivalent	Pilling Co.
K850527	ARTHROSCOPY SUCTION BIOPSY PUNCH	Mar 14, 1985	Substantially Equivalent	T. Korossurgical Instruments Corp.
K850423	CONCEPT SUCTION SLEEVE	Mar 14, 1985	Substantially Equivalent	Concept, Inc.
K841980	SIDE CUTTING SERRATED BLADE	Aug 15, 1984	Substantially Equivalent	Stainless Mfg., Inc.
K842774	CODMAN SUCTION PUNCH-PRODUCT CODES	Jul 27, 1984	Substantially Equivalent	Codman & Shurtleff, Inc.
K842111	KOGAN ENDOSPECULUM 9-1/2	Jun 19, 1984	Substantially Equivalent	J. Sklar Mfg. Co., Inc.
K841982	MENISCOTOME 4MM & 5MM	Jun 19, 1984	Substantially Equivalent	Stainless Mfg., Inc.
K841978	LATERAL RELEASE KNIFE 5MM & 7MM	Jun 19, 1984	Substantially Equivalent	Stainless Mfg., Inc.
K841977	5MM DOUGLE EDGE RING CURETTE	Jun 19, 1984	Substantially Equivalent	Stainless Mfg., Inc.
K841976	HOOK KNIFE 4MM & 5MM	Jun 19, 1984	Substantially Equivalent	Stainless Mfg., Inc.
K841975	ROSETTE KNIFE 4MM	Jun 19, 1984	Substantially Equivalent	Stainless Mfg., Inc.
K841974	RETROGRADE KNIFE 4MM & 5MM	Jun 19, 1984	Substantially Equivalent	Stainless Mfg., Inc.
K841973	BANANA KNIFE SERRATED	Jun 19, 1984	Substantially Equivalent	Stainless Mfg., Inc.
K841972	BANANA KNIFE - K841969-LABELING	Jun 19, 1984	Substantially Equivalent	Stainless Mfg., Inc.
K831772	GUILLOTINE BLADE	Jul 07, 1983	Substantially Equivalent	Ortho Pared Instruments, Inc.
K771915	MICRO OSCILLATING SAW	Oct 21, 1977	Substantially Equivalent	American Sterilizer Co.
K771006	MODIFIED PODIATRY PRODUCTS	Jun 17, 1977	Substantially Equivalent	Dentronix, Inc.
K771005	NEW PODIATRY PRODUCTS	Jun 17, 1977	Substantially Equivalent	Dentronix, Inc.