Knife, Orthopedic

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Shanghai and Guangdong, and 1 other province: 7 hold an FDA registration. 1 is a contract manufacturer.

B-ONE Medical (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
Bandex Industrial Corp. Guangdong, contract manufacturer
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Suzhou Endophix Co., Ltd. Jiangsu
Xinhua Surgical Instrument Co., Ltd. Shandong
Zhangjiagang Alldex Commodity Co., Ltd. Jiangsu

How Is HTS Classified?

Knife, Orthopedic is FDA product code HTS, Class 1, 21 CFR 888.4540.

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 3 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Labeling mix-ups (1) and Packaging process control (1).

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

Knife, Orthopedic

Endophix

Catalogue number MS-3107-02, listed by Suzhou Endophix Co., Ltd., China, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Athlet

Catalogue number Height indicator, listed by Signus Medizintechnik Gmbh, Germany, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Mcilwrath Tendon Knife

Mcilwrath Tendon Knife Double Edge

Knife, Orthopedic

Medtronic Resuable Instruments

Blade EX0315002 Sickle

Knife, Orthopedic

Blunt Curved Blade

Blunt Curved Blade: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Blunt Tip One Side

Blunt Tip One Side: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Instrument

Catalogue number Caliper, listed by Signus Medizintechnik Gmbh, Germany, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Diplomat

Catalogue number Break-off instrument, tulip, listed by Signus Medizintechnik Gmbh, Germany, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Knife, Orthopedic

Knife EX0610205 NON-Dspsble Bayonet

Knife, Orthopedic

b-ONE Hip Specialty

Broach Box Chisel

Knife, Orthopedic

Aesculap

SMILLIE Meniscus Knife, straight, 6 3/4" (170 mm), Fig. 3

Knife, Orthopedic

Conmed

Liberator Knife, 4.5 MM X 150 MM

Knife, Orthopedic

Meniscotome

Meniscotome V-Shaped Curved Blade

Knife, Orthopedic

Illico

SE Curved Wanding Blade

Knife, Orthopedic

b-ONE Hip Instrumentation

Offset Cookie Cutter

Knife, Orthopedic

Freer Mucosa Knife

Catalogue number 345-405, listed by Sontec Instruments, Inc., United States, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Miniature Meniscotome

Meniscotome Miniature V-Shaped Blade Flat Handle

Knife, Orthopedic

Meniscotome V-Blade

Meniscotome V-Blade Shaped Flat Handle

Knife, Orthopedic

Arthroscopic Scalpel Knife

Arthroscopic Meniscotome Scalpel TIP Knurled Handle

Knife, Orthopedic

Sigma

Catalogue number 27401-01, listed by Alphatec Spine, Inc., United States, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Target Endoscopic Instrument

[Target] TIK0001L Indian Knife(Long)

Knife, Orthopedic

Blunt One Side Hip Blade – Sterile

Blunt One Side Hip Blade – Sterile: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Kmedic

7 catalogue numbers from IPN014005, listed by Teleflex Medical LLC, United States, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Juveno™ Femoral Hip System

Modular BOX Chisel

Knife, Orthopedic

Curved Hip Blade, Sharp Tip

Curved Hip Blade, Sharp Tip: 3 catalogue numbers listed by T.A.G Medical Products Agricultural Cooperative Association, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Tendon Knife

Tendon Knife Single Side Sharp Point Blade

Knife, Orthopedic

Battalion

Catalogue number CI-10038, listed by Alphatec Spine, Inc., United States, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Arthroscopic Sickle Knife

Arthroscopic Sickle Knife Universal Handle

Knife, Orthopedic

V. Mueller

Smillie Meniscus Knife Straight, Chisel-Type Blade Overall Length 6-3/4" (17.1CM)

Knife, Orthopedic

Symmetry Downing

Symmetry® Knife, Downing Cartilage, Concave Edge, Curved Blade, 10 in

Knife, Orthopedic

Symmetry Lowe-Breck

Symmetry® Knife, Lowe-Breck Cartilage, Straight Edge, Curved Blade, 10 in

Knife, Orthopedic

Piermattei Smillie Meniscotome

Piermattei Smillie Meniscotome Small

Knife, Orthopedic

Straight Hip Blade, Blunt Tip

Straight Hip Blade, Blunt Tip: 2 catalogue numbers listed by T.A.G Medical Products Agricultural Cooperative Association, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Medline Renewal

8000-0027 Patella Ctr,sst 27 MM X 12M

Knife, Orthopedic

Infinity™

Infinity™ Attachable Double Blade 8 mm x 10 mm

Knife, Orthopedic

Universal Banana Knife

Catalogue number 1271-139UL, listed by Sontec Instruments, Inc., United States, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

BE-ST Sheathed Bayonet Surgical Knife

Sheathed Bayonet Surgical Knife

Knife, Orthopedic

Plif

Plif SG Instruments Ganglion Knife (Slim JIM JR.)

Knife, Orthopedic

Symmetry Derlacki

Symmetry® Mobilizer, Derlacki, Angled

Knife, Orthopedic

RZ Medizintechnik GmbH

Tenolysis Knife Style A for tenolysis superficial & deep to the tendon

Knife, Orthopedic

Nixon Knife

Nixon Knife Straight Serrated Banana Bladeextraextra Large Round Handle

Knife, Orthopedic

MSI Precision Specialty Instruments

Smillie Meniscotome, Arthroscopic, 3mm Blade, Long Round Knurled Handle

Knife, Orthopedic

Foerner Sesamoid Knife

Foerner Sesamoid Knife Single Ended Curved TIP Phenolic Handle

Knife, Orthopedic

Arthroscopic Bayonet Knife

Arthroscopic Bayonet Knife Universal Handle

Knife, Orthopedic

Blunt Curved Hip Blade – Sterile

Blunt curved Hip Blade – Sterile: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Smillie Meniscus Knife

Smillie Meniscus Knife Curved V Tip

Knife, Orthopedic

Integra® Miltex®

Integra® Miltex® Lowe-Breck Cartilage Knife, 10-3/4", Double-Guarded, Straight Edge

Knife, Orthopedic

V. Mueller

V. Mueller CRAIG TOOTHED CUTTER ONLY FOR CRAIG BIOPSY SET OVERALL LENGTH 7-3/8 inches 18.7CM

Knife, Orthopedic

Indian Knife

1.8x200mm

Knife, Orthopedic

Femoral Head Disarticulator Knife

Femoral Head Disarticulator Knife Large Size Curved Blade

Knife, Orthopedic

4WEB Medical

2 catalogue numbers from LSTS-000409, listed by 4WEB Inc., United States, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Knife, Orthopedic

Modified Instrument Cannulated Scalpel

Knife, Orthopedic

Alif

Universal Alif Instrument SET Alif Scalpel, Standard

Knife, Orthopedic

Pilling

4 catalogue numbers from IPN020040, listed by Teleflex Medical LLC, United States, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Avalign

Krull Acetabular Knife OL 195mm (7 5/8") TW11.5mm

Knife, Orthopedic

Winberg Tendon Knife

Catalogue number 1271-157, listed by Sontec Instruments, Inc., United States, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Diplomat MIS

4 catalogue numbers from Length indicator, rod, listed by Signus Medizintechnik Gmbh, Germany, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Arthroscopic Toothed Knife

Arthroscopic Toothed Knife Universal Handle 30 Degree Left Angle

Knife, Orthopedic

Medicon

Smillie meniscotome (chisel) cvd 17cm

Knife, Orthopedic

Knife, Orthopedic

Knives (1) Hook Blade (1) Triangle Blade Endotrac Blade System

Knife, Orthopedic

Bistouri Knife

McIlwraith Bistouri Knife Button End Curved

Knife, Orthopedic

Integra® Jarit®

Integra® Jarit® Lowe-Breck Cartilage Knife, 10-3/4", Double-Guarded, Straight Edge

Knife, Orthopedic

McILWRAITH Bistouri Knife

McIlwraith Bistouri Knife Button Ended Curved 55 Millimeter Blades Quantum

Knife, Orthopedic

Arthroscopic Tendon Knife

Arthroscopic Tendon Knife Round Knurl Handle

Knife, Orthopedic

Symmetry Graft

Symmetry® Impactor, Graft, Double-Ended, End Diameter 7/16 in & 9/16 in, 8 3/4 in

Knife, Orthopedic

Best

Sheathed Bayonet Surgical Knife

Knife, Orthopedic

Foerner Sesamoid Knife Elevator

Foerner Sesamoid Knife Elevator Curved TIP

Knife, Orthopedic

Arthroscopic Hook Knife

Arthroscopic Hook Knife Angled TIP Universal Handle

Knife, Orthopedic

Symmetry Surgical®

Knife, House Incudostapedial Joint, Angled 20°, 0.5 mm x 1.5 mm Blade, 6 1/2 in

Knife, Orthopedic

Novo Surgical

lowe-breck cartilage knife, straight edge, curved blade, 10" (25.5 cm)

Knife, Orthopedic

Millennium

Downing Cartilage Knife, BW 10.5mm OL 266mm (10 1/2")

Knife, Orthopedic

Medline

8000-0026 Patella Ctr,sst 26 MM X 12MM

Knife, Orthopedic

Nasal/Tendon Knife

Nasal/Tendon Knife Double Lance Edge Straight Blade Ceramic Coating

Knife, Orthopedic

Knife, Orthopedic

2 catalogue numbers from 1098, listed by Zimmer, Inc., United States, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Ambler Surgical

Tenolysis knife, #1, double-ended, for tenolysis superficial and deep to the tendon, round handle

Knife, Orthopedic

Curved Hip Blade, Sharp Tip – Sterile

Curved Hip Blade, Sharp Tip – Sterile: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Arthroscopic Banana Knife

Arthroscopic Banana Knife Double Sided Smooth Tips Triangle Handle

Knife, Orthopedic

QuadVantage

QuadVantage 8mm Disposable Blade Set. One blade Kit is used per surgery/ case and then disposed of. Blades included are intended to be used with the QuadVanatage Cobra Harvester (UDI…

Knife, Orthopedic

Novo Surgical Inc.

downing cartilage knife, concave edge, curved blade, 10" (25.5 cm)

Knife, Orthopedic

Paradigm

Paradigm, Retractable Blade, Straight

Knife, Orthopedic

Symmetry Smillie

Symmetry® Knife, Smillie Meniscus, Curved Right, 6 1/4 in

Knife, Orthopedic

Arthroscopic Meniscotome

Arthroscopic Meniscotome Banana Double Sided Serrated Tips Knurled Handle

Knife, Orthopedic

Straight Hip Blade, Sharp Tip

Straight Hip Blade, Sharp Tip: 2 catalogue numbers listed by T.A.G Medical Products Agricultural Cooperative Association, under Knife, Orthopedic. 7 manufacturers in China are registered for this product code.

Knife, Orthopedic

Gsource

Finochietto Rib Spreader Adult large alum blades 2 1/2" [62mm] x 1 1/2" [42mm] with 9 1/2" [245mm] opening

Knife, Orthopedic

HIP Preservation System

HPS Disposable Banana Blade, 279 MM (11 IN)

Knife, Orthopedic

Mcilwraith Tendon Knife

Mcilwraith Tendon Knife Single Edge

Knife, Orthopedic

Joseph Nasal/Tendon Knife

Joseph Nasal/Tendon Knife Curved Edge

Knife, Orthopedic

Smillie Meniscotome

Smillie Meniscotome Straight Blade

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