Swanson

Awl w/ Pointed End

Registry build 21.09.26
13manufacturers in China registered for this device type
3catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (3), Shandong (3), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWJ
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Shanghai Reach Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 30
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Changzhou Jiangsu Contract manufacturer 25
Bothwin (Beijing) Medical Technology Co., Ltd. Beijng Beijing Manufacturer 25

Showing 12 of 13. All 13 manufacturers in China registered for Awl

Record

Regulatory record for Swanson
Listed by Wright Medical Technology, Inc., United States
FDA product code HWJ
Device type Awl
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2016-09-17
Record revised 2022-08-11 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Swanson
Catalogue number Size Status
67810200 In distribution
67810100 Small In distribution
67810102 Large In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 91
HNM Medical HNM Stainless, LLC. 42
Awl Synthes Gmbh 41
General Instruments Alphatec Spine, Inc. 36
Alta Acdf System Highridge Medical, LLC 34
Awl Depuy Spine, Inc. 30
Brickyard Stand-Alone Alif Altus Spine 28
Generic Surgical Instruments CTL Medical Corporation 26
IdentiTi Alphatec Spine, Inc. 23
Indy Standalone Altus Spine 23
Invictus Alphatec Spine, Inc. 22
Tecomet Tecomet, Inc. 21

Showing 12 of 480. All products under Awl

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