Mariner

Pedicle Screw Driver, Continuous Tighting, Tri-Flat

Registry build 21.09.26
18manufacturers in China registered for this device type
33catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (9), Shanghai (3), Guangdong (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HXX
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
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Autocam Medical Devices (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Changzhou Wastonortho Medical Appliance Co., Ltd. Changzhou Jiangsu Contract manufacturer 5
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82

Showing 12 of 18. All 18 manufacturers in China registered for Screwdriver

Record

Regulatory record for Mariner
Listed by Seaspine Orthopedics Corporation, United States
FDA product code HXX
Device type Screwdriver
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2017-02-13
Record revised 2026-02-24 (version 5)

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

Catalogue Numbers

Catalogue numbers for Mariner
Catalogue number Size Status
90-1221 In distribution
90-0720 3mm In distribution
90-2210 1/4 sq In distribution
90-2212 In distribution
90-0211 In distribution
90-0202 In distribution
90-0200 1/4 sq In distribution
90-1224 In distribution
90-1210 In distribution
90-1222 In distribution
90-1214 In distribution
90-0222 In distribution
90-1212 In distribution
90-0204 In distribution
90-0212 In distribution
90-0221 In distribution
90-0223 In distribution
90-1223 In distribution
90-1213 In distribution
90-0220 In distribution
90-0203 In distribution
90-0210 1/4 sq In distribution
90-1701 In distribution
90-0224 In distribution
90-0214 In distribution
90-1703 In distribution
90-1211 In distribution
90-1702 In distribution
90-2220 1/4 Sq In distribution
90-0213 In distribution
90-1220 In distribution
90-1230 In distribution
90-0201 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Tecomet Tecomet, Inc. 939
Screwdriver Synthes Gmbh 485
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 371
Screwdriver Medtronic Sofamor Danek, Inc. 197
Level ONE KLS-Martin L.P. 153
Surgical Instrument Jeil Medical Corporation 116
Invictus Alphatec Spine, Inc. 115
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 110
Bradshaw Medical Inc. Bradshaw Medical Inc. 109
Screwdriver Depuy Spine, Inc. 99
Generic Surgical Instruments CTL Medical Corporation 93
Surgical Direct Surgical Direct, Inc. 85

Showing 12 of 1,263. All products under Screwdriver

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