Cascadia™ Interbody System
AN Lordotic Spreader Size 8.5x24x11 mm, 12°
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.
| 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
| Listed by | VB Spine LLC |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2019-10-31 |
| Record revised | 2026-05-01 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 12 to 260 mm; height 4 to 17 mm; angle 6 to 18 °; width 8.5 to 16 mm |
| Distribution end date | 2024-07-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6101-90884 | Length 22 mm | In distribution |
| 6101-90855 | Length 22 mm | In distribution |
| 6101-90889 | Angle 6 ° | In distribution |
| SP-4208-02 | Angle 12 ° | In distribution |
| 7902-90042 | Length 200 mm | In distribution |
| 6101-90887 | Height 14 mm | In distribution |
| PRO-1069-41 | Angle 12 ° | In distribution |
| PRO-1069-39 | Width 8.5 mm | In distribution |
| 7902-90090 | In distribution | |
| 6101-90860 | Angle 12 ° | In distribution |
| SP-2262-04 | Length 12 mm | In distribution |
| 7902-90043 | Length 220 mm | In distribution |
| 6101-90002 | In distribution | |
| 6101-90863 | Angle 18 ° | In distribution |
| SP-3249-01 | In distribution | |
| PRO-1069-28 | Angle 6 ° | In distribution |
| 6101-90861 | Height 16 mm | In distribution |
| PRO-1069-19 | Angle 12 ° | In distribution |
| PRO-1069-30 | Length 28 mm | In distribution |
| SP-4208-07 | Angle 12 ° | In distribution |
| 6101-90880 | Height 7 mm | In distribution |
| 6101-90879 | Angle 6 ° | In distribution |
| 6101-90869 | Height 10 mm | In distribution |
| 6101-90875 | Height 16 mm | In distribution |
| 6101-90852 | Height 7 mm | In distribution |
| PRO-1069-40 | Width 8.5 mm | In distribution |
| PRO-1069-05 | Angle 6 ° | In distribution |
| 6101-90850 | Angle 12 ° | In distribution |
| PRO-1069-29 | Angle 6 ° | In distribution |
| 7902-90064 | In distribution | |
| 6101-90846 | Height 15 mm | In distribution |
| 7902-90089 | Height 12 mm | In distribution |
| PRO-1069-22 | Width 8.5 mm | In distribution |
| SP-2262-07 | Width 14 mm | In distribution |
| 6101-90848 | Length 22 mm | In distribution |
| 7902-90044 | Length 240 mm | In distribution |
| PRO-1069-10 | Angle 6 ° | In distribution |
| 7902-90037 | In distribution | |
| SP-4208-05 | Angle 12 ° | In distribution |
| 6101-90841 | Length 22 mm | In distribution |
| 6101-90874 | Height 15 mm | In distribution |
| PRO-1069-18 | Height 10 mm | In distribution |
| SP-4208-01 | Height 6 mm | In distribution |
| 6101-90892 | In distribution | |
| 6101-90890 | Length 22 mm | In distribution |
| PRO-1069-33 | Length 28 mm | In distribution |
| SP-4208-10 | Angle 12 ° | In distribution |
| 6101-90844 | Height 13 mm | In distribution |
| 6101-90847 | Height 16 mm | In distribution |
| 6101-90871 | Angle 18 ° | In distribution |
| 6101-90870 | Angle 18 ° | In distribution |
| 6101-90168 | In distribution | |
| SP-2262-08 | Angle 7 ° | In distribution |
| PRO-1069-54 | Height 6 mm | In distribution |
| SP-4208-03 | Length 12 mm | In distribution |
| PRO-1221-01 | In distribution | |
| SP-2262-02 | Width 14 mm | In distribution |
| PRO-1069-17 | Width 8.5 mm | In distribution |
| 6101-90170 | Width 10 mm | In distribution |
| 6101-90886 | Length 22 mm | In distribution |
| 6101-90000 | In distribution | |
| PRO-1069-11 | Height 14 mm | In distribution |
| 6101-90849 | Length 22 mm | In distribution |
| PRO-1069-13 | Length 24 mm | In distribution |
| PRO-1069-12 | Width 8.5 mm | In distribution |
| 6101-90859 | Angle 12 ° | In distribution |
| PRO-1069-27 | Width 8.5 mm | In distribution |
| PRO-1069-34 | Height 10 mm | In distribution |
| PRO-1069-26 | Height 9 mm | In distribution |
| 7902-90045 | Length 260 mm | In distribution |
| SP-2262-03 | Height 7 mm | In distribution |
| PRO-1069-50 | Width 8.5 mm | In distribution |
| PRO-1069-37 | Length 28 mm | In distribution |
| PRO-1069-48 | Length 28 mm | In distribution |
| 6101-90862 | Height 17 mm | In distribution |
| PRO-1207 | In distribution | |
| PRO-1069-38 | Length 28 mm | In distribution |
| 6101-90838 | Length 22 mm | In distribution |
| SP-4208-06 | Width 14 mm | In distribution |
| PRO-1069-52 | Height 4 mm | In distribution |
| 3201-91288 | In distribution | |
| PRO-1069-25 | Height 8 mm | In distribution |
| 7902-90034 | In distribution | |
| PRO-1069-49 | Width 8.5 mm | In distribution |
| PRO-1069-56 | Angle 18 ° | In distribution |
| 6101-90853 | Length 22 mm | In distribution |
| PRO-1069-32 | Angle 6 ° | In distribution |
| 6101-90885 | Height 12 mm | In distribution |
| PRO-1069-36 | Height 12 mm | In distribution |
| 6101-90019 | Height 5 mm | In distribution |
| 6101-90851 | Height 6 mm | In distribution |
| 6101-90138 | In distribution | |
| PRO-1069-42 | Angle 12 ° | In distribution |
| PRO-1069-21 | Width 8.5 mm | In distribution |
| PRO-1069-09 | Width 8.5 mm | In distribution |
| 6101-90867 | Angle 18 ° | In distribution |
| 6101-90836 | Height 5 mm | In distribution |
| 6101-90873 | Height 14 mm | In distribution |
| 6101-90888 | Height 15 mm | In distribution |
| 6101-90839 | Height 8 mm | In distribution |
| 7902-90038 | Length 120 mm | In distribution |
| PRO-1069-43 | Length 28 mm | In distribution |
| 6101-90843 | Angle 6 ° | In distribution |
| SP-4208-08 | Width 14 mm | In distribution |
| PRO-1069-08 | Width 8.5 mm | In distribution |
| 6101-90857 | Angle 12 ° | In distribution |
| 6101-90865 | Angle 18 ° | In distribution |
| 7902-90040 | Length 160 mm | In distribution |
| 6101-90864 | Height 5 mm | In distribution |
| PRO-1165-01 | In distribution | |
| 6101-90767 | In distribution | |
| PRO-1221-02 | In distribution | |
| PRO-1069-07 | Length 24 mm | In distribution |
| 6101-90876 | Length 22 mm | In distribution |
| PRO-1069-46 | Height 9 mm | In distribution |
| 6101-90845 | Height 14 mm | In distribution |
| PRO-1069-16 | Angle 12 ° | In distribution |
| PRO-1069-15 | Length 24 mm | In distribution |
| 7902-90088 | Height 8 mm | In distribution |
| PRO-1069-24 | Width 8.5 mm | In distribution |
| 8030-90207 | In distribution | |
| 6101-90878 | Height 5 mm | In distribution |
| SP-2262-09 | Height 13 mm | In distribution |
| 7902-90091 | In distribution | |
| SP-4208-09 | Length 12 mm | In distribution |
| SP-2262-01 | Length 12 mm | In distribution |
| PRO-1069-35 | Height 11 mm | In distribution |
| 6101-90766 | In distribution | |
| 6101-90866 | Angle 18 ° | In distribution |
| PRO-1069-31 | Height 7 mm | In distribution |
| SP-4208-04 | Height 9 mm | In distribution |
| PRO-1069-55 | Width 8.5 mm | In distribution |
| PRO-1069-53 | Height 5 mm | In distribution |
| SP-2262-10 | Length 12 mm | In distribution |
| 6101-90882 | Height 9 mm | In distribution |
| 6101-90877 | Length 22 mm | In distribution |
| PRO-1069-58 | Length 28 mm | In distribution |
| 6101-90835 | Height 4 mm | In distribution |
| PRO-1069-23 | Height 6 mm | In distribution |
| 6101-90858 | Length 22 mm | In distribution |
| PRO-1069-59 | Height 11 mm | In distribution |
| PRO-1069-04 | Height 7 mm | In distribution |
| SP-2262-06 | Height 10 mm | In distribution |
| 7902-90062 | In distribution | |
| PRO-1069-47 | Angle 12 ° | In distribution |
| 6101-90842 | Height 11 mm | In distribution |
| PRO-1069-51 | Length 28 mm | In distribution |
| 6101-90881 | Angle 6 ° | In distribution |
| SP-2262-11 | Width 14 mm | In distribution |
| PRO-1069-14 | Length 24 mm | In distribution |
| 6101-90883 | Height 10 mm | In distribution |
| 6101-90872 | Angle 18 ° | In distribution |
| 7902-90106 | In distribution | |
| PRO-1069-06 | Height 9 mm | In distribution |
| 6101-90837 | Angle 6 ° | In distribution |
| 6101-90854 | Height 9 mm | In distribution |
| PRO-1069-20 | Length 24 mm | In distribution |
| 6101-90856 | Height 11 mm | In distribution |
| 6101-90840 | Height 9 mm | In distribution |
| 7902-90041 | Length 180 mm | In distribution |
| 7902-90039 | Length 140 mm | In distribution |
| 6101-90868 | Angle 18 ° | In distribution |
| 7902-90092 | In distribution | |
| PRO-1069-57 | Width 8.5 mm | In distribution |
| PRO-1069-45 | Height 8 mm | In distribution |
| PRO-1069-44 | Angle 12 ° | In distribution |
| SP-2262-05 | Angle 7 ° | In distribution |
| SP-2263-02 | Length 13 mm | Withdrawn |
| SP-2263-04 | Height 8 mm | Withdrawn |
| SP-2263-06 | Angle 7 ° | Withdrawn |
| SP-2263-08 | Width 16 mm | Withdrawn |
| SP-2263-09 | Height 13 mm | Withdrawn |
| SP-2263-03 | Length 13 mm | Withdrawn |
| SP-2263-10 | Height 14 mm | Withdrawn |
| SP-2263-05 | Height 9 mm | Withdrawn |
| SP-2263-07 | Length 13 mm | Withdrawn |
| SP-2263-01 | Height 5 mm | Withdrawn |
| SP-2263-11 | Angle 7 ° | Withdrawn |
Same 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.