Dakota Alif System

33 X 27 X 17mm X 20° Trial Rasp

Registry build 21.09.26
7manufacturers in China registered for this device type
53catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (3), Shandong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HRT
Manufacturer City Province Registered as Device types
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
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Shanghai Reach Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28

Record

Regulatory record for Dakota Alif System
Listed by Precision Spine, Inc., United States
FDA product code HRT
Device type Stripper, Surgical
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Manufacturer
Premarket notification Exempt
Record published 2025-03-14

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, serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Dakota Alif System
Catalogue number Size Status
69-RM-2017 In distribution
69-RM-2019 In distribution
69-RM-2013 In distribution
69-RL-0019 In distribution
69-RS-0815 In distribution
69-RM-0813 In distribution
69-RM-0811 In distribution
69-RM-2015 In distribution
69-RL-0013 In distribution
69-RL-0015 In distribution
69-RS-2517 In distribution
69-RL-0011 In distribution
69-RL-1511 In distribution
69-RS-2519 In distribution
69-RM-3017 In distribution
69-RM-2515 In distribution
69-RM-1519 In distribution
69-RM-1517 In distribution
69-RL-0819 In distribution
69-RS-3017 In distribution
69-RS-1513 In distribution
69-RM-1515 In distribution
69-RS-0819 In distribution
69-RL-0811 In distribution
69-RM-0815 In distribution
69-RS-0817 In distribution
69-RS-3019 In distribution
69-RM-0819 In distribution
69-RM-3019 In distribution
69-RS-1515 In distribution
69-RL-0817 In distribution
69-RM-1511 In distribution
69-RM-0011 In distribution
69-RM-0019 In distribution
69-RS-2017 In distribution
69-RM-0017 In distribution
69-RM-0015 In distribution
69-RM-2517 In distribution
69-RS-1517 In distribution
69-RS-1519 In distribution
69-RM-2519 In distribution
69-RS-1511 In distribution
69-RL-1513 In distribution
69-RS-2015 In distribution
69-RS-2019 In distribution
69-RS-2515 In distribution
69-RS-2013 In distribution
69-RM-0817 In distribution
69-RM-0013 In distribution
69-RL-0813 In distribution
69-RL-0815 In distribution
69-RL-0017 In distribution
69-RM-1513 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Millennium Avalign Technologies, Inc. 32
Ambler Surgical Ambler Surgical, LLC 30
Instrument Signus Medizintechnik Gmbh 29
Stripper KLS-Martin L.P. 25
Buxton BioMedical Buxton Biomedical, Inc. 24
Boss Instruments Boss Instruments, Ltd. 18
Surtex Surtex Instruments Ltd 16
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 14
Avalign Avalign Technologies, Inc. 12
Stripper, Surgical Biomet Microfixation 12
Integra® Miltex® Integra LifeSciences Production Corporation 11
Rabea Signus Medizintechnik Gmbh 10

Showing 12 of 62. All products under Stripper, Surgical

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