Kerrison Rongeur Forward Cutting 2mm/18cm

A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open A hand-held…

Registry build 21.09.26

A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.

11manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Shanghai (5), Shandong (3), Jiangsu (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTX
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Changzhou Jiangsu Contract manufacturer 25
Qingdao Zhixing Medical Instrument Co., Ltd. Qingdao Shandong Manufacturer 6

Record

Regulatory record for Kerrison Rongeur Forward Cutting 2mm/18cm
Listed by N S Surgical Company
FDA product code HTX
Device type Rongeur
Device class Class 1
Regulation 21 CFR 888.4540
Premarket notification Exempt
Record published 2023-04-27

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide, Moist Heat or Steam Sterilization, Ultraviolet Light
Label carries lot or batch number, manufacturing date
Sizes Length 18 cm

Catalogue Numbers

Catalogue numbers for Kerrison Rongeur Forward Cutting 2mm/18cm
Catalogue number Size Status
08-018-02 Length 18 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sklar® Sklar Corporation 2,994
Life Instruments Life Instrument Corp. 1,252
Novo Surgical Novo Surgical, Inc. 1,227
Surgical Direct Surgical Direct, Inc. 1,208
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 712
gSource Gsource, LLC. 509
Novo Surgical Inc. Novo Surgical, Inc. 397
Peak MED Peak Medical Distribution Inc 320
Aesculap Aesculap AG 264
MSI Precision Specialty Instruments MED Saver, Inc. 244
Integra® Ruggles®-Redmond™ Integra LifeSciences Production Corporation 239
HNM Medical HNM Stainless, LLC. 186

Showing 12 of 438. All products under Rongeur

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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