Atlantis® Anterior Cervical Plate System

Case 176-516 VA SLF Drill Scrw Blck Base

Registry build 21.09.26
105manufacturers in China registered for this device type
15catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FSM
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 37
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Mobility Source Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 26
Guangdong Shunde LQX Health Technology Inc. Foshan Guangdong Contract manufacturer 24

Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument

Record

Regulatory record for Atlantis® Anterior Cervical Plate System
Listed by Medtronic Sofamor Danek, Inc., United States
FDA product code FSM
Device type Tray, Surgical, Instrument
Device class Class 1
Regulation 21 CFR 878.4800
510(k) K190840
Record published 2017-10-07
Record revised 2025-07-21 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number
Distribution end date 2025-07-11

Catalogue Numbers

Catalogue numbers for Atlantis® Anterior Cervical Plate System
Catalogue number Size Status
176-503 In distribution
876-495L In distribution
176-510 In distribution
176-516 In distribution
6191930 In distribution
7081927 In distribution
3123100 In distribution
176-504 In distribution
176-517 In distribution
176-502 In distribution
3123002 In distribution
176-509 In distribution
7081928 In distribution
X0810599 Withdrawn
X0810597 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
IMS HU-Friedy MFG Co., LLC 2,710
Tray, Surgical, Instrument Synthes Gmbh 1,052
Tray, Surgical, Instrument Medtronic Sofamor Danek, Inc. 1,012
Hu-Friedy MFG Co., LLC. HU-Friedy MFG Co., LLC 666
Aptus Medartis Inc. 588
Acumed Acumed LLC 566
Aesculap Aesculap AG 532
Sklar Sklar Corporation 465
Hu-Friedy HU-Friedy MFG Co., LLC 438
Nordent Manufacturing Inc Nordent Manufacturing Inc 429
Level ONE KLS-Martin L.P. 341
Bahadir USA Bahadir USA LLC 300

Showing 12 of 3,212. All products under Tray, Surgical, Instrument

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