HTS

Product Code: HTS

Products Classified as HTS

4482

Knife, Orthopedic

Orthopedic Manual Surgical Instrument.

Total Product Life Cycle (TPLC) Devices

4482

Knife, Orthopedic

Orthopedic Manual Surgical Instrument.

FDA Consensus Standards

• Knife, Orthopedic [37411]: 21 CFR §888.4540 🔎
• Knife, Orthopedic [31853]: 21 CFR §888.4540 🔎
• Knife, Orthopedic [37809]: 21 CFR §888.4540 🔎
• Knife, Orthopedic [31985]: 21 CFR §888.4540 🔎
• Knife, Orthopedic [37414]: 21 CFR §888.4540 🔎

Pre-market Notifications for HTS

K933921	ACUFLEX DISPOSABLE KNIVES	ACUFEX MICROSURGICAL, INC.
K930507	CUSTOM ORTHOPAEDIC TRAYS (PACKS)	ASSOCIATED MEDICAL PRODUCTS CO.
K882525	SPINAL MICROKNIFE	KARLIN TECHNOLOGY, INC.
K873711	RETROGRADE KNIFE, DISPOSABLE #TM-1613	ARTHROPEDICS, INC.
K873713	TRIANGULAR KNIFE, DISPOSABLE #TM-1611	ARTHROPEDICS, INC.
K873712	STANDARD KNIFE, DISPOSABLE #TM-1610	ARTHROPEDICS, INC.
K873714	BANANA KNIFE, DISPOSABLE #TM-1612	ARTHROPEDICS, INC.
K842820	ARTHROSCOPY KNIVES	MEDTECH INDUSTRIES, INC.

Global Unique Device Identification Database

• 00192896090040: KNIFE, ORTHOPEDIC
• 00192896090033: KNIFE, ORTHOPEDIC
• 00192896084339: KNIFE, ORTHOPEDIC
• 00192896084087: KNIFE, ORTHOPEDIC
• 00192896084070: KNIFE, ORTHOPEDIC
• 00192896084063: KNIFE, ORTHOPEDIC
• 00192896084056: KNIFE, ORTHOPEDIC
• 00192896084049: KNIFE, ORTHOPEDIC
• 00192896084018: KNIFE, ORTHOPEDIC
• 00192896082830: KNIFE, ORTHOPEDIC
• 00192896082823: KNIFE, ORTHOPEDIC
• 00192896058934: KNIFE, ORTHOPEDIC
• 00192896057272: KNIFE, ORTHOPEDIC
• 00192896057265: KNIFE, ORTHOPEDIC
• 00192896057258: KNIFE, ORTHOPEDIC

Maude Adverse Events

4.5MM-15MM LIBERATOR KNIFE	CONMED CORPORATION	2019-02-07
MEDTRONIC	MEDTRONIC SOFAMOR DANEK, INC	2018-08-27
UNKNOWN	K2M, INC.	2016-09-21
KNIFE HANDLE	K2M, INC.	2016-08-17
RASP LIBERATOR KNIFE II, 4.75 X 149MM	CONMED LINVATEC	2015-12-03
SEGWAY ENDOSCOPIC SYSTEM	SEGWAY ORTHOPAEDICS, INC.	2015-05-01
*KNIFE, ORTHOPEDIC	SEGWAY ORTHOPAEDICS	2014-06-17
DISPOSABLE BANANA BLADE	CONMED LINVATEC	2013-05-03
ARTHRO-KNIFE, 2-SIDE POINT	CONMED LINVATEC	2008-11-21
SYNTHES (FRA)	SYNTHES USA	1999-06-07