Olympic

G10 Offset T-Handle, 1/4 SQ. Secure Shaft, 100 IN-LB Torque Limiting

Registry build 21.09.26
53manufacturers in China registered for this device type
80catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LXH
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17

Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument

Record

Regulatory record for Olympic
Listed by Astura Medical, United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published 2021-06-02
Record revised 2025-12-10 (version 10)

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
Sizes Guidewire diameter 1.4 mm; guidewire length 350 to 650 mm; outer diameter 3.5 to 10 mm

Catalogue Numbers

Catalogue numbers for Olympic
Catalogue number Size Status
AZA060075 Outer Diameter 7.5 mm In distribution
AZA005080 Outer Diameter 8 mm In distribution
AZE040350 Guidewire Diameter 1.4 mm In distribution
AZA060045 Outer Diameter 4.5 mm In distribution
AZE050350 Guidewire Diameter 1.4 mm In distribution
AZE040450 Guidewire Diameter 1.4 mm In distribution
AZA026550 Guidewire Diameter 1.4 mm In distribution
AZA025550 Guidewire Diameter 1.4 mm In distribution
AZA006000 In distribution
G900013 In distribution
AZA005090 Outer Diameter 9 mm In distribution
AZE050500 Guidewire Diameter 1.4 mm In distribution
AZE060350 Guidewire Diameter 1.4 mm In distribution
AZE050550 Guidewire Diameter 1.4 mm In distribution
AZE120095 Outer Diameter 9.5 mm In distribution
AZE060450 Guidewire Length 450 mm In distribution
AZA005100 Outer Diameter 10 mm In distribution
AZE120045 Outer Diameter 4.5 mm In distribution
AZA060065 Outer Diameter 6.5 mm In distribution
AZA050080 Outer Diameter 8 mm In distribution
AZA005070 Outer Diameter 7 mm In distribution
AZA026480 Guidewire Diameter 1.4 mm In distribution
AZE070500 Guidewire Diameter 1.4 mm In distribution
AZE130080 Outer Diameter 8.0 mm In distribution
AZE130050 Outer Diameter 5.0 mm In distribution
AZA015000 In distribution
AZA026650 Guidewire Diameter 1.4 mm In distribution
AZE050650 Guidewire Diameter 1.4 mm In distribution
AZA050070 Outer Diameter 7 mm In distribution
G912107 In distribution
AZE130045 Outer Diameter 4.5 mm In distribution
AZE120075 Outer Diameter 7.5 mm In distribution
AZE050450 Guidewire Diameter 1.4 mm In distribution
AZA013000 SINGLE ACTION In distribution
AZE040500 Guidewire Diameter 1.4 mm In distribution
AZA050045 Outer Diameter 4.5 mm In distribution
AZA005060 Outer Diameter 6 mm In distribution
AZA025480 Guidewire Diameter 1.4 mm In distribution
AZA005045 Outer Diameter 4.5 mm In distribution
AZE130070 Outer Diameter 7.0 mm In distribution
AZA014000 SEQUENTIAL ACTION In distribution
AZA005040 Outer Diameter 4 mm In distribution
AZE070450 Guidewire Diameter 1.4 mm In distribution
AZE040480 Guidewire Diameter 1.4 mm In distribution
AZA050100 Outer Diameter 10 mm In distribution
G919554 In distribution
AZA026350 Guidewire Diameter 1.4 mm In distribution
AZE040550 Guidewire Diameter 1.4 mm In distribution
AZA050050 Outer Diameter 5 mm In distribution
AZA021000 In distribution
AZE120055 Outer Diameter 5.5 mm In distribution
G905558 In distribution
AZE070350 Guidewire Diameter 1.4 mm In distribution
G902562 In distribution
AZE060500 Guidewire Diameter 1.4 mm In distribution
AZA050060 Outer Diameter 6 mm In distribution
AZA025650 Guidewire Diameter 1.4 mm In distribution
AZE070550 Guidewire Diameter 1.4 mm In distribution
AZA050090 Outer Diameter 9 mm In distribution
AZE120085 Outer Diameter 8.5 mm In distribution
AZE130060 Outer Diameter 6.0 mm In distribution
AZA060085 Outer Diameter 8.5 mm In distribution
AZE120065 Outer Diameter 6.5 mm In distribution
AZA060055 Outer Diameter 5.5 mm In distribution
AZE060650 Guidewire Diameter 1.4 mm In distribution
AZE070480 Guidewire Diameter 1.4 mm In distribution
AZA025450 Guidewire Diameter 1.4 mm In distribution
AZE040650 Guidewire Diameter 1.4 mm In distribution
AZA005050 Outer Diameter 5 mm In distribution
AZA051000 In distribution
AZA005035 Outer Diameter 3.5 mm In distribution
AZE070650 Guidewire Diameter 1.4 mm In distribution
AZA025500 Guidewire Diameter 1.4 mm In distribution
AZE050480 Guidewire Diameter 1.4 mm In distribution
AZE060550 Guidewire Diameter 1.4 mm In distribution
AZA026450 Guidewire Diameter 1.4 mm In distribution
AZA026500 Guidewire Diameter 1.4 mm In distribution
AZA022000 In distribution
AZE060480 Guidewire Diameter 1.4 mm In distribution
AZA025350 Guidewire Diameter 1.4 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Razek Equipamentos Razek Equipamentos Ltda 11,578
Orthopedic Manual Surgical Instrument Globus Medical, Inc. 4,784
Instrument Howmedica Osteonics Corp 4,539
Orthopedic Manual Surgical Instrument Ortho Development Corp. 4,076
Knee Instruments Medacta International SA 3,944
Kyocera Medical Technologies, Inc. Kyocera Medical Technologies, Inc. 3,420
Arthrex® Arthrex, Inc. 3,106
Spine Instruments Medacta International SA 2,892
Orthopedic Manual Surgical Instrument Medtronic Sofamor Danek, Inc. 2,766
Hip Instruments Medacta International SA 1,904
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 1,756
ReLine Nuvasive, Inc. 1,208

Showing 12 of 9,501. All products under Orthopedic Manual 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