Orio

ORIO Lumbar Cage System, Instruments 1 and Implants Case

Registry build 21.09.26
53manufacturers in China registered for this device type
152catalogue 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 Orio
Listed by Spinecraft LLC, United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2019-04-19
Record revised 2024-09-16 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Orio
Catalogue number Size Status
7040-05-2 In distribution
7050-01 In distribution
7000-1-0161 In distribution
7000-1-0046 In distribution
7020-03-07-S In distribution
7020-04-07 In distribution
7010-01-08B In distribution
7030-02-02SB In distribution
7040-03-A In distribution
7000-1-0046 In distribution
7000-1-0530 In distribution
7020-03-09-S In distribution
7020-03-14 In distribution
7030-01-02 In distribution
7020-04-08 In distribution
7010-06-4 In distribution
7000-1-0045 In distribution
7000-2-0003 In distribution
7000-1-0760 In distribution
7030-03-01 In distribution
7000-1-0169T In distribution
7030-02-01 In distribution
7000-1-0153T In distribution
7010-01-12 In distribution
7020-04-11-S In distribution
7020-03-11-S In distribution
7010-09 In distribution
7000-1-0377 In distribution
7020-04-09-S In distribution
7040-02-02 In distribution
7000-214 In distribution
7020-02-08B In distribution
7030-01-01 In distribution
7010-06-2 In distribution
7020-04-13 In distribution
7040-06 In distribution
7000-212 In distribution
7020-02-13 In distribution
7010-04-4 In distribution
7020-03-12 In distribution
7000-2-0000 In distribution
7010-08 In distribution
7020-02-11-A In distribution
7030-02-02S In distribution
7030-01-01 In distribution
7000-311 In distribution
7000-1-0045 In distribution
7040-02-03 In distribution
7030-03-01B In distribution
7000-1-0506B In distribution
7030-01-02 In distribution
7040-04 In distribution
7020-03-10-S In distribution
7000-1-0525B In distribution
7020-03-08 In distribution
7030-02-01SB In distribution
7000-314 In distribution
7000-1-0361 In distribution
7020-04-15-S In distribution
7000-1-0552 In distribution
7030-02-02 In distribution
7000-1-0145T In distribution
7000-2-0003 In distribution
7000-2-0001 In distribution
7000-1-0540 In distribution
7000-1-0369T In distribution
7030-01-03 In distribution
7000-2-0002 In distribution
7000-1-0377T In distribution
7000-1-0177T In distribution
7020-02-11 In distribution
7010-05-2 In distribution
7000-1-0506 In distribution
7000-1-0153 In distribution
7020-04-10 In distribution
7020-04-15 In distribution
7000-1-0353T In distribution
7000-1-0800 In distribution
7020-04-12-S In distribution
7000-1-0169 In distribution
7020-04-14 In distribution
7000-1-0353 In distribution
7000-1-0506 In distribution
7010-07 In distribution
7000-300 In distribution
7000-313 In distribution
7020-03-09 In distribution
7000-210 In distribution
7030-02-02S In distribution
7010-03-4 In distribution
7000-1-0161T In distribution
7020-04-10-S In distribution
7010-01-08 In distribution
7302-02-01-A In distribution
7000-1-0345 In distribution
7030-02-02 In distribution
7040-03 In distribution
7000-213 In distribution
7020-03-13 In distribution
7010-02-2 In distribution
7000-1-0076 In distribution
7020-02-09-A In distribution
7010-12-2 In distribution
7010-11 In distribution
7010-08B In distribution
7020-04-14-S In distribution
7010-10 In distribution
7020-02-07 In distribution
7020-03-10 In distribution
7030-01-02B In distribution
7000-1-0900 In distribution
7020-02-10B In distribution
7010-20 In distribution
7000-1-0361T In distribution
7030-02-01 In distribution
7000-215 In distribution
7030-03-01 In distribution
7020-04-13-S In distribution
7020-04-12 In distribution
7040-05-1 In distribution
7000-1-0525 In distribution
7010-05-4 In distribution
7020-04-09 In distribution
7030-02-02B In distribution
7000-1-0900W In distribution
7020-04-11 In distribution
7030-02-03S In distribution
7020-03-11 In distribution
7010-12-4 In distribution
7010-04-2 In distribution
7000-211 In distribution
7020-04-08-S In distribution
7020-03-08-S In distribution
7000-1-0345T In distribution
7020-03-13-S In distribution
7000-2-0000 In distribution
7000-1-0145 In distribution
7000-1-0369 In distribution
7010-03-XL In distribution
7030-02-01B In distribution
7020-01 In distribution
7020-03-12-S In distribution
7030-01-01B In distribution
7020-02-09 In distribution
7020-04-07-S In distribution
7030-02-01S In distribution
7020-03-07 In distribution
7040-02-01 In distribution
7030-02-01S In distribution
7000-1-0177 In distribution
7000-1-0076 In distribution
7020-02-12B 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