Apex

Apex Antegrade Femoral Locking Endcap 0mm Length

Registry build 21.09.26
17manufacturers in China registered for this device type
569catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HSB
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
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Turnxon Precision Co., Ltd. Dongguan Guangdong Contract manufacturer 17
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70

Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories

Record

Regulatory record for Apex
Listed by Orthoxel Designated Activity Company
FDA product code HSB
Device type Rod, Fixation, Intramedullary And Accessories
Device class Class 2
Regulation 21 CFR 888.3020
510(k) K181375
Record published 2022-08-10
Record revised 2025-02-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Ambient Storage and Handling
Distribution end date 2021-11-23
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Apex
Catalogue number Size Status
F01-110380 Ø 11.0 x 380mm In distribution
F04-115280 Ø 11.5 x 280mm In distribution
F02-120400 Ø 12.0 x 400mm In distribution
F03-850400 Ø 8.5 x 400mm In distribution
F02-110280 Ø 11.0 x 280mm In distribution
F05-115440 Ø 11.5 x 440mm In distribution
F05-110460 Ø 11.0 x 460mm In distribution
F01-145240 Ø 14.5 x 240mm In distribution
F04-110260 Ø 11.0 x 260mm In distribution
F02-115400 Ø 11.5 x 400mm In distribution
F02-120240 Ø 12.0 x 240mm In distribution
F04-115460 Ø 11.5 x 460mm In distribution
F02-100360 Ø 10.0 x 360mm In distribution
T02-110405 Ø 11 x 405mm In distribution
F04-145460 Ø 14.5 x 460mm In distribution
T02-120420 12 x 420mm In distribution
T02-850405 8.5 x 405mm In distribution
F04-110320 Ø 11.0 x 320mm In distribution
T02-850255 8.5 x 255mm In distribution
F04-120300 Ø 12.0 x 300mm In distribution
E04-010 10mm Length In distribution
F01-120440 Ø 12.0 x 440mm In distribution
F01-115260 Ø 11.5 x 260mm In distribution
F01-100380 Ø 10.0 x 380mm In distribution
F03-130460 Ø 13.0 x 460mm In distribution
F01-115340 Ø 11.5 x 340mm In distribution
T02-100345 Ø 10 x 345mm In distribution
F03-115400 Ø 11.5 x 400mm In distribution
F05-110420 Ø 11.0 x 420mm In distribution
F02-100480 Ø 14.5 x 480mm In distribution
F02-850480 Ø 8.5 x 480mm In distribution
F02-120460 Ø 12.0 x 460mm In distribution
F03-120440 Ø 12.0 x 440mm In distribution
F05-120240 Ø 12.0 x 240mm In distribution
T02-110375 Ø 11 x 375mm In distribution
F05-130240 Ø 13.0 x 240mm In distribution
F01-120320 Ø 12.0 x 320mm In distribution
INS-1001 In distribution
F05-900380 Ø 9.0 x 380mm In distribution
F04-115440 Ø 11.5 x 440mm In distribution
T02-130255 13 x 255mm In distribution
F02-115440 Ø 11.5 x 440mm In distribution
F04-850320 Ø 8.5 x 320mm In distribution
F05-850300 Ø 8.5 x 300mm In distribution
T02-850315 8.5 X 315mm In distribution
T02-120315 12 x 315mm In distribution
F01-100400 Ø 10.0 x 400mm In distribution
F02-120260 Ø 12.0 x 260mm In distribution
F01-850400 Ø 8.5 x 400mm In distribution
F03-110300 Ø 11.0 x 300mm In distribution
INS-1002 In distribution
T02-900255 9.0 x 255mm In distribution
F02-110400 Ø 11.0 x 400mm In distribution
F03-110380 Ø 11.0 x 380mm In distribution
T02-115255 11.5 x 255mm In distribution
F01-130280 Ø 13.0 x 280mm In distribution
F04-850360 Ø 8.5 x 360mm In distribution
F03-145320 Ø 14.5 x 320mm In distribution
F03-145300 Ø 14.5 x 300mm In distribution
T02-130330 13 x 330mm In distribution
F03-145400 Ø 14.5 x 400mm In distribution
F04-145380 Ø 14.5 x 380mm In distribution
F01-120340 Ø 12.0 x 340mm In distribution
F01-100340 Ø 10.0 x 340mm In distribution
T02-900330 Ø 9 x 330mm In distribution
F03-850420 Ø 8.5 x 420mm In distribution
F05-115400 Ø 11.5 x 400mm In distribution
F05-900300 Ø 9.0 x 300mm In distribution
INS-1152 In distribution
F01-130400 Ø 13.0 x 400mm In distribution
F02-130320 Ø 13.0 x 320mm In distribution
F05-900420 Ø 9.0 x 420mm In distribution
F02-110260 Ø 11.0 x 260mm In distribution
T02-850360 8.5 X 360mm In distribution
F03-115420 Ø 11.5 x 420mm In distribution
F01-850300 Femoral Nail PF Left Ø 8.5 x 300mm In distribution
F01-120240 Ø 12.0 x 240mm In distribution
F04-130480 Ø 13.0 x 480mm In distribution
F02-120420 Ø 12.0 x 420mm In distribution
F04-120380 Ø 12.0 x 380mm In distribution
F04-850240 Ø 8.5 x 240mm In distribution
F03-115380 Ø 11.5 x 380mm In distribution
F04-120440 Ø 12.0 x 440mm In distribution
F02-145460 Ø 14.5 x 460mm In distribution
F01-115400 Ø 11.5 x 400mm In distribution
F02-120320 Ø 12.0 x 320mm In distribution
F04-130460 Ø 13.0 x 460mm In distribution
F01-850340 Ø 8.5 x 340mm In distribution
T02-115300 11.5 x 300mm In distribution
E02-010 10mm length In distribution
F04-120280 Ø 12.0 x 280mm In distribution
F03-850380 Ø 8.5 x 380mm In distribution
F03-850240 Ø 8.5 x 240mm In distribution
F02-120480 Ø 12.0 x 480mm In distribution
F05-100380 Ø 10.0 x 380mm In distribution
F03-120480 Ø 12.0 x 480mm In distribution
F05-120280 Ø 12.0 x 280mm In distribution
F03-145380 Ø 14.5 x 380mm In distribution
F02-850360 Ø 8.5 x 360mm In distribution
F02-850340 Ø 8.5 x 340mm In distribution
T02-850270 8.5 X 270mm In distribution
F04-100460 Ø 10.0 x 460mm In distribution
F04-100440 Ø 10.0 x 440mm In distribution
F05-130400 Ø 13.0 x 400mm In distribution
F05-110320 Ø 11.0 x 320mm In distribution
T02-100315 Ø 10 x 315mm In distribution
F01-850260 Ø 8.5 x 260mm In distribution
F02-850320 Ø 8.5 x 320mm In distribution
F02-145280 Ø 14.5 x 280mm In distribution
F01-115240 Ø 11.5 x 240mm In distribution
F02-100300 Ø 10.0 x 300mm In distribution
T02-850420 8.5 x 420mm In distribution
F02-110380 Ø 11.0 x 380mm In distribution
F04-130240 Ø 13.0 x 240mm In distribution
F02-115360 Ø 11.5 x 360mm In distribution
T02-115375 11.5 x 375mm In distribution
F03-115300 Ø 11.5 x 300mm In distribution
T02-130315 13 x 315mm In distribution
F05-850280 Ø 8.5 x 280mm In distribution
F04-145280 Ø 14.5 x 280mm In distribution
F02-115480 Ø 11.5 x 480mm In distribution
F02-110240 Ø 11.0 x 240mm In distribution
F04-100380 Ø 10.0 x 380mm In distribution
T02-115330 11.5 x 330mm In distribution
F04-115260 Ø 11.5 x 260mm In distribution
F01-115320 Ø 11.5 x 320mm In distribution
F01-110400 Ø 11.0 x 400mm In distribution
F01-115300 Ø 11.5 x 300mm In distribution
F05-900340 Ø 9.0 x 340mm In distribution
F01-120360 Ø 12.0 x 360mm In distribution
T02-110330 Ø 11 x 330mm In distribution
F02-145440 Ø 14.5 x 440mm In distribution
F05-100420 Ø 10.0 x 420mm In distribution
F05-850240 Ø 8.5 x 240mm In distribution
F02-115420 Ø 11.5 x 420mm In distribution
E03-015 15mm Length In distribution
E01-010 10mm In distribution
T02-850390 8.5 x 390mm In distribution
F04-130340 Ø 13.0 x 340mm In distribution
F05-130360 Ø 13.0 x 360mm In distribution
F04-120240 Ø 12.0 x 240mm In distribution
F05-115300 Ø 11.5 x 300mm In distribution
T02-120300 12 x 300mm In distribution
F05-110280 Ø 11.0 x 280mm In distribution
F04-100400 Ø 10.0 x 400mm In distribution
F04-130420 Ø 13.0 x 420mm In distribution
E04-000 0mm Length In distribution
INS-1111 In distribution
F03-130360 Ø 13.0 x 360mm In distribution
F02-110440 Ø 11.0 x 440mm In distribution
F05-115280 Ø 11.5 x 280mm In distribution
F05-110440 Ø 11.0 x 440mm In distribution
F03-120340 Ø 12.0 x 340mm In distribution
F02-100340 Ø 10.0 x 340mm In distribution
T02-900270 9.0 x 270mm In distribution
F01-115360 Ø 11.5 x 360mm In distribution
T02-100390 Ø 10 x 390mm In distribution
E02-020 20mm length In distribution
F01-100260 Ø 10.0 x 260mm In distribution
F04-110380 Ø 11.0 x 380mm In distribution
T02-115360 11.5 x 360mm In distribution
F05-110380 Ø 11.0 x 380mm In distribution
F01-110360 Ø 11.0 x 360mm In distribution
F02-130420 Ø 13.0 x 420mm In distribution
F03-115240 Ø 11.5 x 240mm In distribution
F05-130440 Ø 13.0 x 440mm In distribution
F04-850340 Ø 8.5 x 340mm In distribution
F02-130400 Ø 13.0 x 400mm In distribution
F04-130360 Ø 13.0 x 360mm In distribution
F04-850440 Ø 8.5 x 440mm In distribution
F05-100400 Ø 10.0 x 400mm In distribution
F03-130340 Ø 13.0 x 340mm In distribution
F05-120400 Ø 12.0 x 400mm In distribution
F05-850420 Ø 8.5 x 420mm In distribution
F03-145240 Ø 14.5 x 240mm In distribution
T02-900285 Ø 9 x 285mm In distribution
F01-130380 Ø 13.0 x 380mm In distribution
F02-850380 Ø 8.5 x 380mm In distribution
F03-850280 Ø 8.5 x 280mm In distribution
F05-115340 Ø 11.5 x 340mm In distribution
F01-100480 Ø 10.0 x 480mm In distribution
F05-850260 Ø 8.5 x 260mm In distribution
F03-130480 Ø 13.0 x 480mm In distribution
F04-120420 Ø 12.0 x 420mm In distribution
F05-100340 Ø 10.0 x 340mm In distribution
INS-1043 In distribution
F01-100360 Ø 10.0 x 360mm In distribution
F03-120400 Ø 12.0 x 400mm In distribution
F04-130440 Ø 13.0 x 440mm In distribution
F01-850480 Ø 8.5 x 480mm In distribution
F05-120380 Ø 12.0 x 380mm In distribution
F01-115420 Ø 11.5 x 420mm In distribution
F03-145440 Ø 14.5 x 440mm In distribution
F04-115400 Ø 11.5 x 400mm In distribution
T02-120375 12 x 375mm In distribution
F03-120460 Ø 12.0 x 460mm In distribution
F03-850260 Ø 8.5 x 260mm In distribution
F04-850380 Ø 8.5 x 380mm In distribution
F03-100380 Ø 10.0 x 380mm In distribution
F05-120420 Ø 12.0 x 420mm In distribution
F03-120380 Ø 12.0 x 380mm In distribution
F02-145300 Ø 14.5 x 300mm In distribution
F04-120480 Ø 12.0 x 480mm In distribution
LE02-000 0mm length In distribution
F04-850300 Ø 8.5 x 300mm In distribution
F02-110420 Ø 11.0 x 420mm In distribution
F03-110400 Ø 11.0 x 400mm In distribution
F01-850380 Ø 8.5 x 380mm In distribution
F04-110480 Ø 11.0 x 480mm In distribution
F01-145360 Ø 14.5 x 360mm In distribution
F02-145400 Ø 14.5 x 400mm In distribution
F05-120460 Ø 12.0 x 460mm In distribution
F03-850360 Ø 8.5 x 360mm In distribution
F05-120440 Ø 12.0 x 440mm In distribution
F01-130340 Ø 13.0 x 340mm In distribution
F02-120300 Ø 12.0 x 300mm In distribution
F03-120280 Ø 12.0 x 280mm In distribution
F02-130280 Ø 13.0 x 280mm In distribution
F03-115340 Ø 11.5 x 340mm In distribution
F01-145380 Ø 14.5 x 380mm In distribution
F03-145360 Ø 14.5 x 360mm In distribution
F04-115420 Ø 11.5 x 420mm In distribution
T02-130360 13 x 345mm In distribution
F05-900240 Ø 9.0 x 240mm In distribution
F02-130340 Ø 13.0 x 340mm In distribution
F01-145300 Ø 14.5 x 300mm In distribution
F04-130320 Ø 13.0 x 320mm In distribution
T02-900390 Ø 9 x 390mm In distribution
F02-115380 Ø 11.5 x 380mm In distribution
F04-130280 Ø 13.0 x 280mm In distribution
E03-005 5mm Length In distribution
F02-130440 Ø 13.0 x 440mm In distribution
T02-120405 12 x 405mm In distribution
F01-110260 Ø 11.0 x 260mm In distribution
F05-100300 Ø 10.0 x 300mm In distribution
T02-120360 12 x 360mm In distribution
T02-110390 Ø 11 x 390mm In distribution
F05-115360 Ø 11.5 x 360mm In distribution
F03-850300 Ø 8.5 x 300mm In distribution
F04-850280 Ø 8.5 x 280mm In distribution
F04-110340 Ø 11.0 x 340mm In distribution
F02-110300 Ø 11.0 x 300mm In distribution
F01-120380 Ø 12.0 x 380mm In distribution
F04-110300 Ø 11.0 x 300mm In distribution
F01-130240 Ø 13.0 x 240mm In distribution
F01-130440 Ø 13.0 x 440mm In distribution
T02-100375 Ø 10 x 375mm In distribution
F02-120280 Ø 12.0 x 280mm In distribution
F04-100420 Ø 10.0 x 420mm In distribution
E04-005 5mm Length In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
T2 Stryker GmbH 1,373
Autobahn Globus Medical, Inc. 1,258
Gamma Stryker GmbH 1,120
Summa Orthopaedics Femur Nail System Jeil Medical Corporation 742
Arix Femur Nail System Jeil Medical Corporation 742
Orthofix Orthofix SRL 721
Rod, Fixation, Intramedullary And Accessories Synthes Gmbh 715
Trigen Smith & Nephew, Inc. 681
Arthrex® Arthrex, Inc. 665
Precice® Intramedullary Limb Lengthening System NuVasive Specialized Orthopedics, Inc. 596
Natural Nail® Zimmer, Inc. 552
Precice® Bone Transport System NuVasive Specialized Orthopedics, Inc. 546

Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories

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