Cortera Spinal Fixation System

Tray, Full, CC Cann 8.5, IMP INS, Level 1

Registry build 21.09.26
36manufacturers in China registered for this device type
90catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (9), Jiangsu (8), Zhejiang (5). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LRP
Manufacturer City Province Registered as Device types
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Shenzhen Senlede Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 33
Dongguan Shin YI Healthcare Products Factory Dong Guan Guangdong Contract manufacturer 30
Jiangsu Huadong Medical Device Industry Co., Ltd. Yangzhou Jiangsu Contract manufacturer 29
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
JIE GAO Plastic Products Co., Ltd. Dongguan Guangdong Contract manufacturer 11
Shenzhen HYS Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
Guangdong Huilin Packaging Technology Group Co., Ltd. Dongguan Guangdong Contract manufacturer 3
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105

Showing 12 of 36. All 36 manufacturers in China registered for Tray, Surgical

Record

Regulatory record for Cortera Spinal Fixation System
Listed by Xtant Medical Holdings, Inc., United States
FDA product code LRP
Device type Tray, Surgical
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-09-30
Record revised 2025-05-09 (version 2)

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 Cortera Spinal Fixation System
Catalogue number Size Status
1509-200180 In distribution
1509-130040 In distribution
1509-010010 In distribution
1509-110030 In distribution
1509-200160 In distribution
CORR2RCON In distribution
1509-200170 In distribution
1509-120030 In distribution
1509-020370 In distribution
1509-200130 In distribution
1509-200100 In distribution
1509-020360 In distribution
1509-230050 In distribution
1509-020330 In distribution
1509-300010 In distribution
1509-020280 In distribution
1509-020080 In distribution
1509-200020 In distribution
1509-020310 In distribution
1509-110010 In distribution
1509-120060 In distribution
1509-230100 In distribution
1509-200090 In distribution
1509-010150 In distribution
1509-020100 In distribution
1509-210110 In distribution
1509-210020 In distribution
1509-200200 In distribution
1509-200240 In distribution
1509-010030 In distribution
1509-230030 In distribution
1509-000010 In distribution
1509-020060 In distribution
1509-020040 In distribution
1509-230110 In distribution
1509-210030 In distribution
1509-230070 In distribution
1509-300020 In distribution
1509-010040 In distribution
1509-020300 In distribution
1509-120090 In distribution
1509-020050 In distribution
1509-120010 In distribution
1509-020010 In distribution
1509-020250 In distribution
1509-020096 In distribution
1509-300030 In distribution
1509-020200 In distribution
1509-020340 In distribution
1509-200010 In distribution
1509-020270 In distribution
1509-200250 In distribution
1509-210100 In distribution
1509-230020 In distribution
1509-010210 In distribution
1509-210070 In distribution
1509-210140 In distribution
1509-110020 In distribution
1509-200110 In distribution
1509-020090 In distribution
1509-010020 In distribution
1509-020030 In distribution
1509-020290 In distribution
1509-210040 In distribution
1509-000020 In distribution
1509-020110 In distribution
1509-200150 In distribution
1509-020320 In distribution
1509-230080 In distribution
1509-120070 In distribution
1509-210080 In distribution
1509-020095 In distribution
1509-020240 In distribution
1509-210130 In distribution
1509-120080 In distribution
1509-230010 In distribution
1509-200120 In distribution
1509-010090 In distribution
1509-120020 In distribution
1509-120040 In distribution
1509-020260 In distribution
1509-210050 In distribution
1509-020070 In distribution
1509-200070 In distribution
1509-230040 In distribution
1509-210010 In distribution
1509-200030 In distribution
1509-120050 In distribution
1509-020020 In distribution
1509-010100 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 12,037
Centurion Centurion Medical Products Corporation 2,023
Medline Medline Industries, Inc. 773
PST Trays Ambler Surgical, LLC 128
AngioSystems Tray Angiosystems, Inc. 126
Tray, Surgical Wright Medical Technology, Inc. 123
Medin Corporation Ambler Surgical, LLC 96
Aligned Medical Solutions Aligned Medical Solutions 92
Stradis Stradis Healthcare 91
SteriBest Surgical Products Corp. 84
Elmed Elmed, Inc. 79
SteriBest Mastel Surgical Inc. 76

Showing 12 of 808. All products under Tray, 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