Pyrenees® Cervical Plate System

Variable Drill Guide, Single Barrel Screw Thru, Size Single Barrel Screw Thru

Registry build 21.09.26
14manufacturers in China registered for this device type
393catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KWQ
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
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
APS Materials Suzhou Suzhou Jiangsu Contract manufacturer 18
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Suzhou Jiangsu Manufacturer 34
Double Medical Technology Inc. Xiamen Fujian Contract manufacturer 14

Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body

Record

Regulatory record for Pyrenees® Cervical Plate System
Listed by VB Spine LLC
FDA product code KWQ
Device type Appliance, Fixation, Spinal Intervertebral Body
Device class Class 2
Regulation 21 CFR 888.3060
Record published 2016-05-10
Record revised 2026-04-20 (version 11)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Sizes Length 5 to 110 mm; outer diameter 3.5 to 5 mm
Distribution end date 2025-01-06

Catalogue Numbers

Catalogue numbers for Pyrenees® Cervical Plate System
Catalogue number Size Status
6801-13814C Outer Diameter 3.9 mm In distribution
208-43F60A 3 Level In distribution
201-04014C Outer Diameter 4 mm In distribution
201-44D76 4 Level In distribution
SP-4141-11 Length 15 mm In distribution
6801-13512D Length 12 mm In distribution
6801-13524C Length 24 mm In distribution
201-90031 In distribution
6808-90007 In distribution
6808-90010 In distribution
201-14022C Outer Diameter 4 mm In distribution
6808-44S14H Length 14 mm In distribution
201-90029 In distribution
6808-44S10H 1 Level In distribution
208-43F66 3 Level In distribution
6801-13512C Outer Diameter 3.5 mm In distribution
208-43F54 Length 54 mm In distribution
6712-04312C Outer Diameter 4.35 mm In distribution
201-42D40 2 Level In distribution
6808-90005 In distribution
6808-90000 In distribution
6808-90003 In distribution
6712-04510C Outer Diameter 4.5 mm In distribution
SP-1722 In distribution
208-42F42A Length 42 mm In distribution
6808-44S12H 1 Level In distribution
6712-04314C Outer Diameter 4.35 mm In distribution
6801-13822D Length 22 mm In distribution
208-41F22 Length 22 mm In distribution
6801-13816D Outer Diameter 3.9 mm In distribution
208-44F65 Length 65 mm In distribution
SP-872 In distribution
201-14012D Length 12 mm In distribution
201-42D42 Length 42 mm In distribution
6801-13812C Length 12 mm In distribution
208-45F105 Length 105 mm In distribution
6801-13518C Outer Diameter 3.5 mm In distribution
201-44D72 4 Level In distribution
6808-90014 In distribution
SP-4141-06 Length 10 mm In distribution
201-04316C Diameter 4.35 mm In distribution
208-44F69 Length 69 mm In distribution
6712-04016C Length 16 mm In distribution
201-41D25 Length 25 mm In distribution
6808-44S14Y 1 Level In distribution
208-41F28 Length 28 mm In distribution
201-14510C Length 10 mm In distribution
208-41F26 1 Level In distribution
6801-13818D Length 18 mm In distribution
6801-13514D Length 14 mm In distribution
201-14320C Length 20 mm In distribution
6808-44S9H Length 9 mm In distribution
208-43F75 3 Level In distribution
201-90101 In distribution
6712-04518C Outer Diameter 4.5 mm In distribution
6808-44S6H 1 Level In distribution
201-44D68 Length 68 mm In distribution
6712-04014D Outer Diameter 4 mm In distribution
6808-90008 In distribution
6808-44S5H 1 Level In distribution
208-44F81 4 Level In distribution
208-43F72 Length 72 mm In distribution
201-04012C Outer Diameter 4 mm In distribution
201-90099 In distribution
208-43F66A Length 66 mm In distribution
201-14310C Length 10 mm In distribution
201-14314C 4.35mm Diameter In distribution
201-41D23 1 Level In distribution
6808-44S8Y Length 8 mm In distribution
6712-04012C Length 12 mm In distribution
208-43F51 Length 51 mm In distribution
201-90023 In distribution
6808-44S11Y Length 11 mm In distribution
6808-90004 In distribution
201-42D52 Length 52 mm In distribution
201-43D68 3 Level In distribution
208-42F44 2 Level In distribution
201-14312C 4.35mm Diameter In distribution
6808-90032 In distribution
6808-44S7Y Length 7 mm In distribution
201-14522C Length 22 mm In distribution
6808-43S14H 1 Level In distribution
6801-13522D Length 22 mm In distribution
6801-13524D Length 24 mm In distribution
201-90019 In distribution
6808-43S15H 1 Level In distribution
SP-2480 In distribution
6712-04020D Outer Diameter 4 mm In distribution
201-04014D Outer Diameter 4 mm In distribution
201-04518C Outer Diameter 4.5 mm In distribution
208-43F63 3 Level In distribution
201-04514C Outer Diameter 4.5 mm In distribution
208-44F97 Length 97 mm In distribution
201-42D36 2 Level In distribution
6808-90006 In distribution
201-14010C Outer Diameter 4 mm In distribution
208-44F93 4 Level In distribution
6801-13810C Length 10 mm In distribution
6808-43S12H 1 Level In distribution
6808-43S7H 1 Level In distribution
201-04312C Length 12 mm In distribution
208-43F48 Length 48 mm In distribution
SP-4141-07 Length 11 mm In distribution
201-04314C Diameter 4.35 mm In distribution
201-90259 In distribution
6808-44S9Y 1 Level In distribution
201-04318C Diameter 4.35 mm In distribution
208-42F38 Length 38 mm In distribution
201-42D50 Length 50 mm In distribution
201-14520C Outer Diameter 4.5 mm In distribution
6712-04310C Length 10 mm In distribution
201-14316C 4.35mm Diameter In distribution
208-45F95 Length 95 mm In distribution
6712-04020C Outer Diameter 4 mm In distribution
6801-13820D Length 20 mm In distribution
201-90032 In distribution
208-42F36A Length 36 mm In distribution
208-41F34 1 Level In distribution
201-14016D Length 16 mm In distribution
208-44F89 Length 89 mm In distribution
6808-44S13H 1 Level In distribution
208-44F101 Length 101 mm In distribution
6808-43S13H Length 13 mm In distribution
6801-13514C Length 14 mm In distribution
201-04016D Outer Diameter 4 mm In distribution
6808-90009 In distribution
6808-90013 In distribution
201-43D71 Length 71 mm In distribution
6801-13520C Length 20 mm In distribution
201-14010D Length 10 mm In distribution
201-90065 In distribution
6712-04022C Length 22 mm In distribution
201-04512C Outer Diameter 4.5 mm In distribution
201-43D62 Length 62 mm In distribution
208-41F30 1 Level In distribution
208-41F18 1 Level In distribution
6801-13812D Outer Diameter 3.9 mm In distribution
201-04012D Length 12 mm In distribution
208-44F77 Length 77 mm In distribution
6808-44S15Y Length 15 mm In distribution
6808-90011 In distribution
201-14014C Length 14 mm In distribution
SP-4141-10 Length 14 mm In distribution
201-41D33 1 Level In distribution
201-14518C Outer Diameter 4.5 mm In distribution
208-43F69 3 Level In distribution
201-41D35 1 Level In distribution
6801-13510D Length 10 mm In distribution
6712-04012D Length 12 mm In distribution
6801-13522C Outer Diameter 3.5 mm In distribution
6712-04018D Length 18 mm In distribution
6808-90012 In distribution
208-43F78 3 Level In distribution
208-43F60 3 Level In distribution
201-14018C Length 18 mm In distribution
6712-04022D Outer Diameter 4 mm In distribution
6801-13820C Length 20 mm In distribution
6801-13826C Length 26 mm In distribution
6808-43S11H 1 Level In distribution
6801-13520D Length 20 mm In distribution
6712-04018C Outer Diameter 4 mm In distribution
6808-43S10H Length 10 mm In distribution
208-44F73 4 Level In distribution
SP-4141-01 Length 5 mm In distribution
6801-13824D Length 24 mm In distribution
201-44D80 4 Level In distribution
6808-43S6H 1 Level In distribution
208-43F63A Length 63 mm In distribution
201-41D31 1 Level In distribution
SP-1372 In distribution
208-41F24 Length 24 mm In distribution
201-42D44 Length 44 mm In distribution
6801-13516C Length 16 mm In distribution
6712-04320C Diameter 4.35 mm In distribution
208-42F48 2 Level In distribution
201-43D59 Length 59 mm In distribution
SP-4141-04 Length 8 mm In distribution
208-45F110 Length 110 mm In distribution
201-14512C Outer Diameter 4.5 mm In distribution
6712-04316C Length 16 mm In distribution
201-42D46 Length 46 mm In distribution
208-41F38 1 Level In distribution
201-42D38 Length 38 mm In distribution
201-44D88 Length 88 mm In distribution
6801-13814D Outer Diameter 3.9 mm In distribution
6808-43S5H Length 5 mm In distribution
6801-13510C Length 10 mm In distribution
208-42F54 2 Level In distribution
SP-4141-05 Length 9 mm In distribution
208-42F34 2 Level In distribution
201-04016C Length 16 mm In distribution
6712-04322C Diameter 4.35 mm In distribution
6801-13516D Length 16 mm In distribution
208-42F46 2 Level In distribution
6801-13518D Length 18 mm In distribution
SP-4141-02 Length 6 mm In distribution
6712-04014C Length 14 mm In distribution
SP-5001 In distribution
SP-4141-09 Length 13 mm In distribution
208-42F42 2 Level In distribution
6712-04514C Length 14 mm In distribution
201-43D53 Length 53 mm In distribution
201-04516C Length 16 mm In distribution
6712-04512C Length 12 mm In distribution
201-44D92 4 Level In distribution
208-42F36 Length 36 mm In distribution
6801-13816C Outer Diameter 3.9 mm In distribution
6712-04522C Length 22 mm In distribution
SP-4141-08 Length 12 mm In distribution
6808-90001 In distribution
208-44F61 Length 61 mm In distribution
6808-44S7H 1 Level In distribution
208-43F57 3 Level In distribution
6808-44S11H Length 11 mm In distribution
201-41D29 Length 29 mm In distribution
6801-13818C Outer Diameter 3.9 mm In distribution
208-41F32 Length 32 mm In distribution
6808-43S8H 1 Level In distribution
201-41D37 1 Level In distribution
208-41F20 Length 20 mm In distribution
SP-1812 In distribution
6712-04520C Outer Diameter 4.5 mm In distribution
SP-4141-03 Length 7 mm In distribution
6808-44S12Y Length 12 mm In distribution
201-90181 In distribution
6808-44S15H Length 15 mm In distribution
201-04018D Length 18 mm In distribution
6808-90002 In distribution
208-42F40 Length 40 mm In distribution
6808-44S10Y Length 10 mm In distribution
208-42F48A Length 48 mm In distribution
201-42D48 2 Level In distribution
201-04018C Length 18 mm In distribution
208-41F36 Length 36 mm In distribution
6712-04516C Outer Diameter 4.5 mm In distribution
201-43D56 3 Level In distribution
6801-13526D Length 26 mm In distribution
6712-04016D Outer Diameter 4 mm In distribution
201-41D27 Length 27 mm In distribution
201-90176 In distribution
6808-44S8H 1 Level In distribution
201-14516C Length 16 mm In distribution
6801-13824C Length 24 mm In distribution
6712-04010D Outer Diameter 4 mm In distribution
6712-04318C Length 18 mm In distribution
6808-43S9H 1 Level In distribution
6801-13822C Length 22 mm In distribution
201-14318C 4.35mm Diameter In distribution
208-42F52 2 Level In distribution
6801-13526C Length 26 mm In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
ReLine Nuvasive, Inc. 2,998
CD Horizon® Spinal System Medtronic Sofamor Danek, Inc. 2,568
Creo Globus Medical, Inc. 1,765
AccelFix Spinal Fixation System L&K Biomed Co., Ltd. 1,755
Ozark Cervical Plate System VB Spine LLC 1,460
Sirion Astura Medical 1,246
Apex Spine System Spinecraft LLC 1,187
AnyPlus Spinal Fixation System GS Medical Co., Ltd. 986
Astra Spine System Spinecraft LLC 970
Zavation Zavation 966
ACP Nuvasive, Inc. 918
Polaris™ 5.5 Spinal System Biomet Spine 877

Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body

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