Alpine XC Adjustable Fusion System

Spiked Rasp 1/4IN Quick Connect 12MM

Registry build 21.09.26
12manufacturers in China registered for this device type
41catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (4), Guangdong (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 HTR
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
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Changzhou Jiangsu Contract manufacturer 25
Shenzhen Xiazhifeng Electronic Co., Ltd. Shenzhen Guangdong Contract manufacturer 25

Record

Regulatory record for Alpine XC Adjustable Fusion System
Listed by Highridge Medical, LLC, United States
FDA product code HTR
Device type Rasp
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2025-11-07

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 Alpine XC Adjustable Fusion System
Catalogue number Size Status
6200-1618 In distribution
6200-1010 In distribution
6200-1008 In distribution
6200-1610 In distribution
6200-2608 In distribution
6200-1710 In distribution
6200-1614 In distribution
6200-1718 In distribution
6200-1412 In distribution
6200-1714 In distribution
6200-2514 In distribution
6200-1416 In distribution
6200-2516 In distribution
6200-2512 In distribution
6200-1708 In distribution
6200-1803 In distribution
6200-2510 In distribution
6200-2610 In distribution
6200-2508 In distribution
6200-1418 In distribution
6200-1801 In distribution
6200-1712 In distribution
6200-1012 In distribution
6200-2718 In distribution
6200-1018 In distribution
6200-1616 In distribution
6200-1802 In distribution
6200-1414 In distribution
6200-2812 In distribution
6200-1006 In distribution
6200-2806 In distribution
6200-1612 In distribution
6200-1716 In distribution
6200-2816 In distribution
6200-1014 In distribution
6200-1016 In distribution
6200-1706 In distribution
6200-2414 In distribution
6200-2808 In distribution
6200-2518 In distribution
6200-1608 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. 240
TiWAVE C Cervical Cage System Kalitec Direct, LLC 232
Tranquil-C™ Nexus Spine, L.L.C. 158
Calix Spinal Implant System Xtant Medical Holdings, Inc. 143
Rasp Medtronic Sofamor Danek, Inc. 109
Specials Seaspine Orthopedics Corporation 109
Stryker Avalign Technologies, Inc. 105
Endoskeleton® TAS Medtronic Sofamor Danek, Inc. 93
Intervertebral Disc Preparation Instruments Alphatec Spine, Inc. 90
Cambria Seaspine Orthopedics Corporation 85
IdentiTi Alphatec Spine, Inc. 83
Link Instruments – Rasps, compressors and broaches Waldemar Link GmbH & Co. KG 83

Showing 12 of 378. All products under Rasp

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