Lateral Retractor
Auxiliary Blade, 140mm x 6mm
34manufacturers in China registered for this device type
71catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (7), Zhejiang (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Showing 12 of 34. All 34 manufacturers in China registered for Retractor
Record
| Listed by | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | GAD |
| Device type | Retractor |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-06-03 |
| Record revised | 2025-10-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 95-6880 | 170mm | In distribution |
| 95-6932 | 90mm | In distribution |
| 95-6947 | 140mm x 6mm | In distribution |
| 95-6943 | 100mm x 6mm | In distribution |
| 95-6912 | 90mm | In distribution |
| 95-6878 | 150mm | In distribution |
| 95-6832 | 90mm | In distribution |
| 95-6874 | 110mm | In distribution |
| 95-6856 | 130mm | In distribution |
| 95-6896 | 130mm | In distribution |
| 95-6931 | 80mm | In distribution |
| 95-6834 | 110mm | In distribution |
| 95-6804 | 7mm | In distribution |
| 95-6811 | In distribution | |
| 95-6857 | 140mm | In distribution |
| 95-6916 | 130mm | In distribution |
| 95-6942 | 90mm x 6mm | In distribution |
| 95-6899 | 160mm | In distribution |
| 95-6877 | 140mm | In distribution |
| 95-6891 | 80mm | In distribution |
| 95-6950 | 170mm x 6mm | In distribution |
| 95-6853 | 100mm | In distribution |
| 95-6935 | 120mm | In distribution |
| 95-6936 | 130mm | In distribution |
| 95-6941 | 80mm x 6mm | In distribution |
| 95-6833 | 100mm | In distribution |
| 95-6875 | 120mm | In distribution |
| 95-6836 | 130mm | In distribution |
| 95-6915 | 120mm | In distribution |
| 95-6920 | 170mm | In distribution |
| 95-6945 | 120mm x 6mm | In distribution |
| 95-6812 | In distribution | |
| 95-6858 | 150mm | In distribution |
| 95-6897 | 140mm | In distribution |
| 95-6854 | 110mm | In distribution |
| 95-6825 | In distribution | |
| 95-6879 | 160mm | In distribution |
| 95-6873 | 100mm | In distribution |
| 95-6835 | 120mm | In distribution |
| 95-6949 | 160mm x 6mm | In distribution |
| 95-6918 | 150mm | In distribution |
| 95-6855 | 120mm | In distribution |
| 95-6948 | 150mm x 6mm | In distribution |
| 95-6900 | 170mm | In distribution |
| 95-6851 | 80mm | In distribution |
| 95-6895 | 120mm | In distribution |
| 95-6859 | 160mm | In distribution |
| 95-6837 | 140mm | In distribution |
| 95-6911 | 80mm | In distribution |
| 95-6898 | 150mm | In distribution |
| 95-6840 | 170mm | In distribution |
| 95-6933 | 100mm | In distribution |
| 95-6871 | 80mm | In distribution |
| 95-6944 | 110mm x 6mm | In distribution |
| 95-6917 | 140mm | In distribution |
| 95-6860 | 170mm | In distribution |
| 95-6913 | 100mm | In distribution |
| 95-6919 | 160mm | In distribution |
| 95-6838 | 150mm | In distribution |
| 95-6872 | 90mm | In distribution |
| 95-6831 | 80mm | In distribution |
| 95-6839 | 160mm | In distribution |
| 95-6876 | 130mm | In distribution |
| 95-6934 | 110mm | In distribution |
| 95-6894 | 110mm | In distribution |
| 95-6937 | 140mm | In distribution |
| 95-6914 | 110mm | In distribution |
| 95-6946 | 130mm x 6mm | In distribution |
| 95-6852 | 90mm | In distribution |
| 95-6893 | 100mm | In distribution |
| 95-6892 | 90mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thompson | Thompson Surgical Instruments, Inc. | 4,354 |
| Millennium | Avalign Technologies, Inc. | 2,128 |
| Surtex | Surtex Instruments Ltd | 1,318 |
| Life Instruments | Life Instrument Corp. | 1,135 |
| Innomed, Inc. | Innomed, Inc. | 1,017 |
| Aesculap | Aesculap AG | 1,013 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 973 |
| Elmed | Elmed, Inc. | 919 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 891 |
| Boss Instruments | Boss Instruments, Ltd. | 799 |
| gSource | Gsource, LLC. | 753 |
| Sklar® | Sklar Corporation | 753 |
Showing 12 of 2,238. All products under Retractor
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-05-17 | Class II | Under Investigation by firm | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure | 21 units |
| 2024-05-17 | Class II | Under Investigation by firm | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure | 31 units |
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.