Impulse Interbody Spacer System

Bayonet Downgoing Curette 7mm x 11mm

Registry build 21.09.26
53manufacturers in China registered for this device type
115catalogue 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 Impulse Interbody Spacer System
Listed by Degen 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, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-05-29
Record revised 2026-02-09 (version 3)

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 Outer diameter 6 to 16 mm; height 4 to 6 mm

Catalogue Numbers

Catalogue numbers for Impulse Interbody Spacer System
Catalogue number Size Status
07-54D08 In distribution
07-50D14 Outer Diameter 14 mm In distribution
07-43D In distribution
07-83D18 In distribution
07-09D14 Outer Diameter 14 mm In distribution
07-56D06 In distribution
07-09D12 Outer Diameter 12 mm In distribution
07-10D07 Outer Diameter 7 mm In distribution
07-44D In distribution
07-21M In distribution
07-82D10 In distribution
07-84D13 Outer Diameter 13 mm In distribution
07-20M In distribution
07-83D08 In distribution
07-09D10 Outer Diameter 10 mm In distribution
07-07M In distribution
07-84D12 Outer Diameter 12 mm In distribution
07-09D15 Outer Diameter 15 mm In distribution
99-50H4 In distribution
07-09D11 Outer Diameter 11 mm In distribution
07-79D08 In distribution
07-50D15 Outer Diameter 15 mm In distribution
07-53D10 In distribution
07-09D07 Outer Diameter 7 mm In distribution
07-10D13 Outer Diameter 13 mm In distribution
99-50H3 In distribution
07-42D In distribution
07-78D10 In distribution
07-54D10 In distribution
07-77D In distribution
07-50D07 Outer Diameter 7 mm In distribution
07-55D10 In distribution
07-53D08 In distribution
07-09D08 Outer Diameter 8 mm In distribution
07-81D08 In distribution
07-09D09 Outer Diameter 9 mm In distribution
07-82D06 In distribution
07-72D In distribution
07-06M In distribution
07-56D08 In distribution
07-79D18 In distribution
07-52D08 In distribution
07-84D15 Outer Diameter 15 mm In distribution
07-68D In distribution
07-46D In distribution
07-76D In distribution
07-79D00 In distribution
07-10D09 Outer Diameter 9 mm In distribution
07-50D06 Outer Diameter 6 mm In distribution
07-78D08 In distribution
07-82D08 In distribution
99-18H In distribution
07-10D12 Outer Diameter 12 mm In distribution
07-84D16 Outer Diameter 16 mm In distribution
07-09D16 Outer Diameter 16 mm In distribution
07-81D12 In distribution
07-10D16 Outer Diameter 16 mm In distribution
99-50H5 In distribution
07-10D14 Outer Diameter 14 mm In distribution
07-40D In distribution
07-50D13 Outer Diameter 13 mm In distribution
07-50D12 Outer Diameter 12 mm In distribution
07-84D09 Outer Diameter 9 mm In distribution
07-51D12 In distribution
07-71D In distribution
07-55D08 In distribution
07-80D12 In distribution
07-10D15 Outer Diameter 15 mm In distribution
07-69D In distribution
07-51D08 In distribution
07-45D In distribution
07-84D14 Outer Diameter 14 mm In distribution
99-50H7 In distribution
99-50H2 In distribution
07-79D10 In distribution
07-70D In distribution
07-50D11 Outer Diameter 11 mm In distribution
99-50H6 In distribution
07-50D09 Outer Diameter 9 mm In distribution
07-87M In distribution
07-50D08 Outer Diameter 8 mm In distribution
99-50H1 In distribution
07-74D In distribution
07-51D06 In distribution
07-16S06 Height 6 mm In distribution
07-75D In distribution
07-47D In distribution
07-10D08 Outer Diameter 8 mm In distribution
07-41D In distribution
07-80D08 In distribution
07-84D06 Outer Diameter 6 mm In distribution
07-78D18 In distribution
07-53D12 In distribution
07-84D10 Outer Diameter 10 mm In distribution
07-84D11 Outer Diameter 11 mm In distribution
07-78D00 In distribution
07-52D10 In distribution
07-50D10 Outer Diameter 10 mm In distribution
07-09D06 Outer Diameter 6 mm In distribution
07-52D12 In distribution
07-50D16 Outer Diameter 16 mm In distribution
07-73D In distribution
07-84D08 Outer Diameter 8 mm In distribution
07-81D10 In distribution
07-09D13 Outer Diameter 13 mm In distribution
07-80D10 In distribution
07-10D11 Outer Diameter 11 mm In distribution
07-82D12 In distribution
07-49D In distribution
07-11M In distribution
07-84D07 Outer Diameter 7 mm In distribution
07-10D10 Outer Diameter 10 mm In distribution
07-51D10 In distribution
07-16S04 Height 4 mm In distribution
07-48D 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