Autobahn

AUTOBAHN Antegrade/Retrograde Femoral Nail Oblique Aiming Module, PF

Registry build 21.09.26
31manufacturers in China registered for this device type
1,255catalogue numbers in this listing
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWC
Manufacturer City Province Registered as Device types
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
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
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11

Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone

Record

Regulatory record for Autobahn
Listed by Globus Medical, Inc., United States
FDA product code HWC
Device type Screw, Fixation, Bone
Device class Class 2
Regulation 21 CFR 888.3040
Establishment Manufacturer, Exporter
510(k) K171108
Record published 2019-06-28
Record revised 2025-02-06 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date
Sizes Length 5 to 500 mm; outer diameter 4 to 15 mm

Catalogue Numbers

Catalogue numbers for Autobahn
Catalogue number Size Status
1183.1828 Length 285 mm In distribution
1257.8385 In distribution
1257.3138S In distribution
5183.1137 Length 375 mm In distribution
1190.5123S Outer Diameter 6.5 mm In distribution
1190.2443S Outer Diameter 14 mm In distribution
1257.5116S In distribution
1183.1118 Outer Diameter 11 mm In distribution
1190.1539S Outer Diameter 15 mm In distribution
7183.7020S Length 20 mm In distribution
7183.5085 Outer Diameter 5 mm In distribution
1190.3926S Entry, PF In distribution
1190.1936S Entry, GT In distribution
1190.1542S Entry, GT In distribution
5183.1348S Length 480 mm In distribution
7183.8025S Length 25 mm In distribution
1183.2078 Fully Threaded In distribution
1183.7043 Partially Threaded In distribution
7183.4045 Fully Threaded In distribution
7183.8040 Outer Diameter 4 mm In distribution
1190.3544S Entry, PF In distribution
1190.7125 In distribution
1176.0220S Right In distribution
1183.8040S Length 40 mm In distribution
5183.1318S Length 180 mm In distribution
7183.3125 Length 125 mm In distribution
7183.7120 Partially Threaded In distribution
1257.5242S In distribution
1176.0120 In distribution
7183.7030S Outer Diameter 5 mm In distribution
5183.1227 Outer Diameter 12 mm In distribution
7183.5023 Length 22.5 mm In distribution
1190.3033S Length 330 mm In distribution
5183.1342 Length 420 mm In distribution
1183.0038S Outer Diameter 4 mm In distribution
5183.1528 Outer Diameter 15 mm In distribution
1190.3521S Outer Diameter 15 mm In distribution
7183.5128S Outer Diameter 5 mm In distribution
1183.6075 Length 75 mm In distribution
1176.5242S Degree, 130° In distribution
1190.2321S Entry, GT In distribution
7183.0050 Partially Threaded In distribution
1183.4020 Length 20 mm In distribution
1176.3932S In distribution
1190.1135S Outer Diameter 11 mm In distribution
5183.1325 Length 255 mm In distribution
1176.3934S In distribution
7183.3070S Length 70 mm In distribution
7183.6063 Outer Diameter 4 mm In distribution
1183.1336 Outer Diameter 13 mm In distribution
1183.1431 Outer Diameter 14 mm In distribution
1176.9211S In distribution
7183.0118 Partially Threaded In distribution
1190.2228S Outer Diameter 12 mm In distribution
7183.3050 Outer Diameter 5 mm In distribution
5183.1127 Outer Diameter 11 mm In distribution
7183.2115S Outer Diameter 5 mm In distribution
7183.7113S Partially Threaded In distribution
1183.1231S Outer Diameter 12 mm In distribution
1183.1516 Outer Diameter 15 mm In distribution
7183.5083 Outer Diameter 5 mm In distribution
5183.1124 Length 240 mm In distribution
1176.6236S Right In distribution
5183.1818S Outer Diameter 8 mm In distribution
1257.8333 In distribution
1257.4040S In distribution
1257.6120S In distribution
1257.8525S In distribution
1183.6055 Partially Threaded In distribution
1176.3142S Outer Diameter 11 mm In distribution
1190.1432S Length 320 mm In distribution
1183.1048S Outer Diameter 10 mm In distribution
7183.7095 Outer Diameter 5 mm In distribution
1190.6055 In distribution
7183.3118S Outer Diameter 5 mm In distribution
1183.1428 Length 285 mm In distribution
1190.5115S Length 115 mm In distribution
1183.2050S Fully Threaded In distribution
7183.5058 Length 57.5 mm In distribution
1190.6050S Outer Diameter 6.5 mm In distribution
7183.4088 Length 87.5 mm In distribution
7183.6085 Partially Threaded In distribution
5183.1921S Outer Diameter 9 mm In distribution
1183.6118S Length 117.5 mm In distribution
1190.9805S Length 5 mm In distribution
1176.5138S Outer Diameter 11 mm In distribution
1190.3244S Entry, PF In distribution
1190.2921S Entry, GT In distribution
7183.4020S Length 20 mm In distribution
1190.1250S Length 500 mm In distribution
1190.1534S Length 340 mm In distribution
5183.1145 Length 450 mm In distribution
1183.2065S Fully Threaded In distribution
1183.1231 Outer Diameter 12 mm In distribution
1190.1547S Outer Diameter 15 mm In distribution
1190.1022S Left In distribution
7183.3113S Outer Diameter 5 mm In distribution
1183.1333 Outer Diameter 13 mm In distribution
6257.1056 In distribution
7183.5038 Outer Diameter 5 mm In distribution
1257.6036S In distribution
7183.5105 Length 105 mm In distribution
1183.1245S Outer Diameter 12 mm In distribution
1190.6073S Length 72.5 mm In distribution
1183.2120S Fully Threaded In distribution
5183.1046 Length 465 mm In distribution
6257.1001 In distribution
1183.8100 Outer Diameter 4 mm In distribution
7183.7095S Length 95 mm In distribution
1190.1229S Outer Diameter 12 mm In distribution
1257.2238S In distribution
1183.3108 Partially Threaded In distribution
1183.7055 Partially Threaded In distribution
7183.8085 Length 85 mm In distribution
1183.1846S Length 465 mm In distribution
1190.3538S Length 380 mm In distribution
7183.5120S Fully Threaded In distribution
1183.1943S Length 435 mm In distribution
1183.1149S Outer Diameter 11 mm In distribution
1190.9015 In distribution
7183.7035 Partially Threaded In distribution
1190.2941S Right In distribution
5183.1122S Length 225 mm In distribution
7183.2048 Outer Diameter 5 mm In distribution
1190.1235S Outer Diameter 12 mm In distribution
1183.6110 Partially Threaded In distribution
5183.1336 Length 360 mm In distribution
5183.1922S Length 225 mm In distribution
1190.5053S Length 52.5 mm In distribution
7183.5093 Length 92.5 mm In distribution
1190.3336S Length 360 mm In distribution
6183.1015 In distribution
1183.1243S Length 435 mm In distribution
1190.2037S Outer Diameter 10 mm In distribution
7183.2083S Outer Diameter 5 mm In distribution
1257.0200 In distribution
1257.6028S In distribution
5183.1243 Length 435 mm In distribution
7183.5098S Outer Diameter 5 mm In distribution
1190.2047S Right In distribution
7183.6105S Length 105 mm In distribution
7183.4023 Length 22.5 mm In distribution
1183.4038S Fully Threaded In distribution
1190.6115 In distribution
1176.6936S In distribution
1190.2243S Length 430 mm In distribution
1190.2445S Length 450 mm In distribution
1257.5138S In distribution
1183.4068S Length 67.5 mm In distribution
5183.1522 Length 225 mm In distribution
7183.0078 Partially Threaded In distribution
1257.8340S In distribution
1190.1538S Outer Diameter 15 mm In distribution
1257.8338S In distribution
1190.2331S Entry, GT In distribution
1190.3029S Outer Diameter 10 mm In distribution
1190.7105 In distribution
1183.0030 Length 30 mm In distribution
7183.0128 Partially Threaded In distribution
1183.3065S Outer Diameter 5 mm In distribution
1183.5073 Length 72.5 mm In distribution
1190.1041S Entry, GT In distribution
5183.1328S Length 285 mm In distribution
1257.2134S In distribution
1176.6232S Right In distribution
1190.1446S Entry, GT In distribution
1190.2428S Entry, GT In distribution
1190.2530S Entry, GT In distribution
1183.8033S Outer Diameter 4 mm In distribution
1183.2088 Outer Diameter 5 mm In distribution
1183.6025 Outer Diameter 4 mm In distribution
1190.7078S Outer Diameter 6.5 mm In distribution
1183.6023S Partially Threaded In distribution
1257.8530S In distribution
1183.6120S Outer Diameter 4 mm In distribution
1183.7090 Length 90 mm In distribution
7183.7118S Outer Diameter 5 mm In distribution
1183.7085 Length 85 mm In distribution
1183.7115S Partially Threaded In distribution
1183.6033 Partially Threaded In distribution
1183.3083 Length 82.5 mm In distribution
1190.2031S Outer Diameter 10 mm In distribution
5183.1448 Outer Diameter 14 mm In distribution
7183.0065 Length 65 mm In distribution
1190.3332S Length 320 mm In distribution
1176.5917S In distribution
1190.6070 In distribution
1183.1218 Outer Diameter 12 mm In distribution
5183.1831S Length 315 mm In distribution
1183.3053S Outer Diameter 5 mm In distribution
1190.2342S Right In distribution
5183.1048S Outer Diameter 10 mm In distribution
5183.1221 Length 210 mm In distribution
1183.5075S Outer Diameter 5 mm In distribution
1183.0095 Partially Threaded In distribution
5183.1925S Outer Diameter 9 mm In distribution
1183.4023S Outer Diameter 4 mm In distribution
7183.7033 Partially Threaded In distribution
1190.3233S Entry, PF In distribution
1183.2053 Length 52.5 mm In distribution
7183.7053 Partially Threaded In distribution
1190.3330S Outer Diameter 13 mm In distribution
1183.4103 Fully Threaded In distribution
1183.7060 Outer Diameter 5 mm In distribution
7257.7350 In distribution
1183.5030S Length 30 mm In distribution
5183.1446S Outer Diameter 14 mm In distribution
1190.3232S Outer Diameter 12 mm In distribution
1190.6115S Length 115 mm In distribution
1190.7110 In distribution
7183.0058 Length 57.5 mm In distribution
1183.6050S Outer Diameter 4 mm In distribution
1190.1119S Entry, GT In distribution
1183.1439S Length 390 mm In distribution
5183.1034S Length 345 mm In distribution
1183.3045 Outer Diameter 5 mm In distribution
1183.1018S Length 180 mm In distribution
7183.4130 Length 130 mm In distribution
1183.2130S Length 130 mm In distribution
1190.2132S Right In distribution
1257.6038S In distribution
7183.0073 Outer Diameter 4 mm In distribution
7183.0068S Partially Threaded In distribution
1190.1016S Left In distribution
1190.2446S Entry, GT In distribution
1183.1025 Outer Diameter 10 mm In distribution
1176.4036S Degree, 125° In distribution
1183.1418 Outer Diameter 14 mm In distribution
1183.5040S Fully Threaded In distribution
1257.5132S In distribution
1183.1246S Outer Diameter 12 mm In distribution
1183.4128S Fully Threaded In distribution
7183.3058S Outer Diameter 5 mm In distribution
1190.1435S Left In distribution
1176.5017S Outer Diameter 10 mm In distribution
1190.1344S Length 440 mm In distribution
1190.2216S Right In distribution
1257.8350 In distribution
7183.3060 Length 60 mm In distribution
7183.3130 Partially Threaded In distribution
5183.1242 Length 420 mm In distribution
1183.0055 Length 55 mm In distribution
7183.6113 Outer Diameter 4 mm In distribution
1257.8560S In distribution
1190.3950S Length 500 mm In distribution
1257.6142S In distribution
7183.2100 Fully Threaded In distribution
1190.3419S Outer Diameter 14 mm In distribution
1183.4035 Length 35 mm In distribution
5183.1939 Length 390 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
Screw, Fixation, Bone Synthes Gmbh 3,975
Aptus Medartis Inc. 3,623
Acumed Acumed LLC 3,187
Arthrex® Arthrex, Inc. 2,781
OsteoMed Osteomed 2,764
Screw, Fixation, Bone AAP Implantate AG 2,176
Screw, Fixation, Bone Zimmer, Inc. 1,993
Arix System Bone Screw Jeil Medical Corporation 1,875
Cannulated Screw System + Tyber Medical 1,814
Cannulated Compression Headless Screw Tyber Medical 1,621
Microware Bone Plates and Bone Screws Microware Precision Co., Ltd. 1,601
Anthem Globus Medical, Inc. 1,538

Showing 12 of 5,775. All products under Screw, Fixation, Bone

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K222409 2022-09-08
K162825 2017-05-01
K112028 2011-12-09

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