Chisel (Osteotome)

Which Manufacturers in China Make This?

2 manufacturers in China hold an FDA registration for this device type, based in Shandong and Shanghai.

Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Xinhua Surgical Instrument Co., Ltd. Shandong

How Is KDG Classified?

Chisel (Osteotome) is FDA product code KDG, Class 1, 21 CFR 878.4820.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 14 recalls under this product code since 2017. None was by a company in China. The root causes the FDA records most often are Error in labeling (12) and Process design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Chisel (Osteotome)

Anterior Straight Osteotomes Set

Anterior Straight Osteotomes Set 43cm 17" Consists of the Following: 1 x 7452-56, 1 x 7452-59, 1 x 7452-62, 1 x 7452-66, 1 x 7452-69 & 7452-90

Chisel (Osteotome)

Avalign

O.S.U. Pattern Osteotome,

Chisel (Osteotome)

Univation X

Univation X Osteophyte Removal Osteotom

Chisel (Osteotome)

KeyLift™

Catalogue number KeyLift™, listed by Flospine LLC, United States, under Chisel (Osteotome). 2 manufacturers in China are registered for this product code.

Chisel (Osteotome)

Koros-Scaglietti Osteotome Set

Koros-Scaglietti Osteotome Straight 22cm 8-3/4" Set Consists of the Following: 1 x 7455-06, 1 x 7455-09, 1 x 7455-12, 1 x 7455-16, 1 x 7455-19, 1 x 7455-50

Chisel (Osteotome)

IQ

IQ Osteotome Fine CVD 20/205MM

Chisel (Osteotome)

HNM Medical

Cottle Crosbar, 6MM, ANG

Chisel (Osteotome)

Millennium

Cement Removal V-Shaped Chisel, 3 1/2" shaft, phenolic handle, 8 3/4" OL

Chisel (Osteotome)

Vacuum Collection Bottle

Vacuum Collection Bottle, Collect Larger Volumes OF Fluid From Procedures

Chisel (Osteotome)

LCU Hip System – Instruments

Orthopaedic joint/limb rongeur - LCU Hip System

Chisel (Osteotome)

Cottle Gubisch Chisel

Cottle Gubisch Chisel Slopped Chiseled TIP/Blade

Chisel (Osteotome)

Symmetry Stille

Symmetry® Chisel, Stille, Straight, 25 mm Tip Width, 8 in

Chisel (Osteotome)

Comfort Plus Osteotome Set

Comfort Plus Osteotome Straight 16.5cm Handles Set Consists of the Following: 1 x 7530-06, 1 x 7530-10, 1 x 7530-15, 1 x 7530-20, 1 x 7530-25 & 1 x 7530-30

Chisel (Osteotome)

Enduro

Enduro Tibia Chisel RM/LL

Chisel (Osteotome)

Stille Chisels

CHISEL ORIGINAL STILLE 12 mm 16.5 cm 6.5 in

Chisel (Osteotome)

Chisel (Osteotome)

Flex Osteotome-Round, ME

Chisel (Osteotome)

General Instrument

Modular Box Chisel

Chisel (Osteotome)

Comfort Plus Chisel Set

Comfort Plus Chisel Straight 16.5cm Set Consists of the Following: 1 x 7540-06, 1 x 7540-10, 1 x 7540-15, 1 x 7540-20, 1 x 7540-25, 1 x 7540-30

Chisel (Osteotome)

Symmetry Lexer

Symmetry® Chisel, Lexer, 15 mm Tip Width, 8 5/8 in

Chisel (Osteotome)

Husky Plus Osteotome

Husky Plus Osteotome Straight 10mm, 16cm Shaft, 39cm Total Length

Chisel (Osteotome)

Koros-Scaglietti Chisel Set

Koros-Scaglietti Long Chisel Straight 27.5cm 10-78" Set Consists of the Following: 1 x 7462-06, 1 x 7462-09, 1 x 7462-12, 1 x 7462-16 & 1 x 7462-19

Chisel (Osteotome)

Novo Surgical Inc.

u.s. army pattern chisel, straight, 6 1/4" (16.0 cm), 6.0 mm

Chisel (Osteotome)

Knife

Lebsche Sternal Knife 1.25” blade, 10”

Chisel (Osteotome)

Boss Instruments

Chisel, "Hockey Stick", right

Chisel (Osteotome)

Pitanguy Osteotome

Pitanguy Osteotome Semi Guarded U-Shaped TIP

Chisel (Osteotome)

Medline

ZS-110 Rayhack Ulnar/Radial Shrtening O

Chisel (Osteotome)

Aesculap

Kolbel-Type Penetrating Gouge 3MM. 185MM

Chisel (Osteotome)

Medtronic Resuable Instruments

Chisel 2143009 Angled BOX Chisel - 6MM

Chisel (Osteotome)

Chisel (Osteotome)

Chisel 2143010 Angled BOX Chisel - 10MM

Chisel (Osteotome)

Spark – Instruments

Orthopaedic chisel - Gemini SL Total Knee System

Chisel (Osteotome)

Symmetry Surgical

Symmetry® Chisel, Bone Chisel Stout, #3

Chisel (Osteotome)

Hermann Medizintechnik GmbH

LEXER bone chisel, 8 3/4" 22cm/15mm

Chisel (Osteotome)

Life Instruments

Long Chisel 3/4" Str 1 1/4", 5" handle pinned

Chisel (Osteotome)

Symmetry Hibbs

Symmetry® Osteotome, Hibbs, Curved, 1/2 in (12 mm) Wide, 9 1/2 in, 241 mm

Chisel (Osteotome)

Symmetry Lambotte

Symmetry® Osteotome, Mini-Lambotte, Straight, 12 mm, 5 1/8 in, 130 mm

Chisel (Osteotome)

Elmed

Neivert osteotome. Guarded. Straight. Cutting edge 5mm. Overall length 8in (20.3cm).

Chisel (Osteotome)

Husky Plus Chisel

Husky Plus Chisel Straight 15mm, 16cm Shaft, 39cm Total Length

Chisel (Osteotome)

Elmed Incorporated

Neivert osteotome. Guarded. Straight. Cutting edge 5mm. Overall length 8in (20.3cm).

Chisel (Osteotome)

Osteotome

Lateral Osteotome Straight Tip with Offset Handle, 10mm, 8-1/2" Shaft 21.5cm, 9-3/4" 25cm Handle, Total Length 18-1/4" 46.5cm

Chisel (Osteotome)

Link Instruments – Chisel, Bone Curette, Raspatory, Rongeur

14 catalogue numbers from 130-780, listed by Waldemar Link GmbH & Co. KG, Germany, under Chisel (Osteotome). 2 manufacturers in China are registered for this product code.

Chisel (Osteotome)

Chisel

Koros-Scaglietti Long Chisel 16mm Straight 28cm 11" Length

Chisel (Osteotome)

Orthomed

Chisel Blade 16MM STR. FOR OM49-0630

Chisel (Osteotome)

Anmuth Medical International

STILLE Chisel Straight 20mm wide, 8"

Chisel (Osteotome)

Quinelato

Mini Lambotte Osteotome 12,5cm straight 08mm

Chisel (Osteotome)

Comfort Plus Chisel

Comfort Plus Chisel 20mm Straight 16.5cm Handles 29cm Total Length

Chisel (Osteotome)

Ambler Surgical

Amputation chisel, 5 1/4'', extra large, curved edge, hexagonal handle

Chisel (Osteotome)

Medtronic Reusable Instruments

Chisel EX0318024 4MM Angl BX - 40DEG RGT

Chisel (Osteotome)

Symmetry Cottle

Symmetry® Chisel, Cottle Crossbar, Straight, 12 mm

Chisel (Osteotome)

Prima

8 catalogue numbers from 15070K, listed by Keystone Dental Inc., United States, under Chisel (Osteotome). 2 manufacturers in China are registered for this product code.

Chisel (Osteotome)

Silver Osteotome

Silver Osteotome Single Guard Blade Right Curved TIP

Chisel (Osteotome)

Columbus Revision

Columbus REV Guide F/Femur BOX Chisel

Chisel (Osteotome)

Stille Osteotomes

HAND OSTEOTOME STILLE 12 mm curved blade R45 mm phenolic handle 16 cm 6.25 in

Chisel (Osteotome)

Princeton

Elevator/Osteotome Family Alexander Periosteal Double Ended 12MM Serrated 8.25"

Chisel (Osteotome)

Comfort Plus Osteotome

Comfort Plus Osteotome 10mm Straight 16.5cm Handles 29cm Total Length

Chisel (Osteotome)

Novo Surgical

lexer chisel, w/ sterilizable (up to 143 degrees c) plastic handle, 25.0 mm, 8 5/8" (22.0 cm)

Chisel (Osteotome)

Surgical Direct

7 inch Bone File, double end no. 12A pattern, one end plain, other end cross serrated

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer