Sigma
Independent Blade ARM, Offset Right, 1.5", Sigma Alif
34manufacturers in China registered for this device type
551catalogue numbers in this listing
1recall
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 | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | GAD |
| Device type | Retractor |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-01-15 |
| Record revised | 2024-04-08 (version 3) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 269-150-110 | In distribution | |
| 401-1245 | In distribution | |
| 169-100-120 | In distribution | |
| 280-150-N30 | In distribution | |
| 270-100-100-R | In distribution | |
| 400-T25-140 | In distribution | |
| 360-261-35 | In distribution | |
| 170-100-110-R | In distribution | |
| 360-222-40 | In distribution | |
| 169-600 | In distribution | |
| 331-2180-A | In distribution | |
| 360-221-35 | In distribution | |
| 250-150-N28 | In distribution | |
| 360-222-35 | In distribution | |
| 170-100-070-L | In distribution | |
| 330-1120-P | In distribution | |
| 400-T50-160 | In distribution | |
| 331-1140-P | In distribution | |
| 401-T25-240 | In distribution | |
| 331-2180-P | In distribution | |
| 170-110-120-R | In distribution | |
| 330-100 | In distribution | |
| 170-100-060-R | In distribution | |
| 169-200-100 | In distribution | |
| 270-100-050-R | In distribution | |
| 170-130-080-L | In distribution | |
| 350-221-55 | In distribution | |
| 360-213-40 | In distribution | |
| 330-2140-A | In distribution | |
| 401-200 | In distribution | |
| 400-600-25 | In distribution | |
| 401-1170 | In distribution | |
| 401-1185 | In distribution | |
| 360-003 | In distribution | |
| 400-T50-080 | In distribution | |
| 360-201-30 | In distribution | |
| 270-100-090-R | In distribution | |
| 400-520 | In distribution | |
| 169-100-060 | In distribution | |
| 270-120-110-L | In distribution | |
| 330-3140 | In distribution | |
| 280-000-120 | In distribution | |
| 400-R25-180 | In distribution | |
| 169-100-070 | In distribution | |
| 269-150-120 | In distribution | |
| 360-261-45 | In distribution | |
| 170-110-070-R | In distribution | |
| 331-3160 | In distribution | |
| 280-000-150 | In distribution | |
| 350-071-10 | In distribution | |
| 330-2120-A | In distribution | |
| 350-211-50 | In distribution | |
| 401-1255 | In distribution | |
| 170-110-120-L | In distribution | |
| 330-200 | In distribution | |
| 401-R25-160 | In distribution | |
| 250-150-N30 | In distribution | |
| 401-R25-140 | In distribution | |
| 360-212-35 | In distribution | |
| 269-450-R | In distribution | |
| 350-212-80 | In distribution | |
| 270-100-120-R | In distribution | |
| 400-T25-080 | In distribution | |
| 270-120-060-R | In distribution | |
| 270-100-110-R | In distribution | |
| 170-110-060-L | In distribution | |
| 401-T25-080 | In distribution | |
| 330-018 | In distribution | |
| 270-120-050-R | In distribution | |
| 250-000-100 | In distribution | |
| 270-130-080-L | In distribution | |
| 270-100-050-L | In distribution | |
| 401-T50-160 | In distribution | |
| 401-R25-120 | In distribution | |
| 360-214-55 | In distribution | |
| 170-130-090-R | In distribution | |
| 270-130-100-L | In distribution | |
| 169-100-100 | In distribution | |
| 360-251-40 | In distribution | |
| 331-1120-P | In distribution | |
| 170-100-080-R | In distribution | |
| 270-100-070-R | In distribution | |
| 350-213-45 | In distribution | |
| 360-222-70 | In distribution | |
| 360-232 | In distribution | |
| 269-150-070 | In distribution | |
| 331-2160-A | In distribution | |
| 331-035 | In distribution | |
| 270-130-150-R | In distribution | |
| 270-120-140-L | In distribution | |
| 331-3100 | In distribution | |
| 401-R25-060 | In distribution | |
| CI-10531-200-080 | In distribution | |
| 360-214-70 | In distribution | |
| 401-T50-060 | In distribution | |
| 350-201-45 | In distribution | |
| 280-000-160 | In distribution | |
| 401-T25-140 | In distribution | |
| 400-T50-240 | In distribution | |
| 400-420 | In distribution | |
| 350-211-60 | In distribution | |
| 400-115 | In distribution | |
| 350-221-60 | In distribution | |
| 360-070-15 | In distribution | |
| 400-T50-140 | In distribution | |
| 330-010 | In distribution | |
| 170-120-070-R | In distribution | |
| 270-120-120-R | In distribution | |
| 350-211-55 | In distribution | |
| 330-008 | In distribution | |
| 270-130-040-L | In distribution | |
| 360-251-80 | In distribution | |
| 401-R25-220 | In distribution | |
| 270-100-150-L | In distribution | |
| 350-211-70 | In distribution | |
| 360-251-50 | In distribution | |
| 331-1180-A | In distribution | |
| 350-221-35 | In distribution | |
| 270-120-100-R | In distribution | |
| 280-000-130 | In distribution | |
| 400-T25-220 | In distribution | |
| 360-213-45 | In distribution | |
| 330-3180 | In distribution | |
| 270-100-040-L | In distribution | |
| 360-202-30 | In distribution | |
| 269-400-R | In distribution | |
| 330-1140-P | In distribution | |
| 400-T25-160 | In distribution | |
| 330-016 | In distribution | |
| 269-150-090 | In distribution | |
| 350-213-50 | In distribution | |
| 401-1360 | In distribution | |
| 270-100-140-L | In distribution | |
| 350-213-40 | In distribution | |
| 350-211-40 | In distribution | |
| 330-1160-A | In distribution | |
| 350-070-10 | In distribution | |
| 360-202-45 | In distribution | |
| 400-R25-060 | In distribution | |
| 401-1460 | In distribution | |
| 250-150-W26 | In distribution | |
| 330-2180-P | In distribution | |
| 360-212-70 | In distribution | |
| 360-202-60 | In distribution | |
| 270-120-070-L | In distribution | |
| 331-2120-A | In distribution | |
| 360-261-40 | In distribution | |
| 400-510 | In distribution | |
| 401-R25-080 | In distribution | |
| 400-T25-060 | In distribution | |
| 400-T50-180 | In distribution | |
| 331-2100-A | In distribution | |
| 170-120-050-R | In distribution | |
| 400-T50-120 | In distribution | |
| 401-T25-060 | In distribution | |
| 350-212-55 | In distribution | |
| 401-T25-220 | In distribution | |
| 330-2180-A | In distribution | |
| 270-100-120-L | In distribution | |
| 350-212-50 | In distribution | |
| 170-110-090-R | In distribution | |
| 331-1120-A | In distribution | |
| 400-200 | In distribution | |
| 331-1160-A | In distribution | |
| 360-202-50 | In distribution | |
| 270-100-150-R | In distribution | |
| 270-100-110-L | In distribution | |
| 350-221-50 | In distribution | |
| 170-110-050-L | In distribution | |
| 269-100-060 | In distribution | |
| 270-130-090-L | In distribution | |
| 270-120-150-R | In distribution | |
| 350-212-45 | In distribution | |
| 400-T50-060 | In distribution | |
| 360-213-55 | In distribution | |
| 270-130-120-R | In distribution | |
| 269-100-100 | In distribution | |
| 270-130-130-L | In distribution | |
| 400-600-20 | In distribution | |
| 401-420 | In distribution | |
| 250-000-140 | In distribution | |
| 170-130-100-R | In distribution | |
| 401-1515 | In distribution | |
| 360-071-15 | In distribution | |
| 360-251-60 | In distribution | |
| 360-201-35 | In distribution | |
| 170-130-120-R | In distribution | |
| 360-211-80 | In distribution | |
| 350-212-40 | In distribution | |
| 401-1285 | In distribution | |
| 330-011 | In distribution | |
| 280-000-140 | In distribution | |
| 360-202-35 | In distribution | |
| 330-3120 | In distribution | |
| 269-400-L | In distribution | |
| 270-130-150-L | In distribution | |
| 170-120-090-R | In distribution | |
| 169-400 | In distribution | |
| 401-T25-200 | In distribution | |
| 360-261-50 | In distribution | |
| 170-130-100-L | In distribution | |
| 401-1480 | In distribution | |
| 270-120-140-R | In distribution | |
| 350-211-45 | In distribution | |
| 400-175 | In distribution | |
| 401-T25-100 | In distribution | |
| 270-130-080-R | In distribution | |
| 360-231 | In distribution | |
| 360-201-70 | In distribution | |
| 360-201-80 | In distribution | |
| 270-100-130-R | In distribution | |
| 350-201-70 | In distribution | |
| 331-2160-P | In distribution | |
| 169-100-080 | In distribution | |
| 401-R25-200 | In distribution | |
| 269-000 | In distribution | |
| 170-110-050-R | In distribution | |
| 360-214-60 | In distribution | |
| 350-221-45 | In distribution | |
| 280-150-N26 | In distribution | |
| 269-150-060 | In distribution | |
| 360-221-80 | In distribution | |
| 269-200-060 | In distribution | |
| 350-213-60 | In distribution | |
| 330-015-R | In distribution | |
| 400-600-15 | In distribution | |
| 331-019 | In distribution | |
| 269-150-080 | In distribution | |
| 170-110-080-R | In distribution | |
| 330-2140-P | In distribution | |
| 280-000-060 | In distribution | |
| 350-003 | In distribution | |
| 350-231 | In distribution | |
| 360-072-15 | In distribution | |
| 170-120-090-L | In distribution | |
| 269-700 | In distribution | |
| 280-150-W26 | In distribution | |
| 170-120-110-L | In distribution | |
| 269-200-050 | In distribution | |
| 270-130-120-L | In distribution | |
| 170-100-120-R | In distribution | |
| 170-130-050-L | In distribution | |
| 400-T18-100 | In distribution | |
| 360-211-35 | In distribution | |
| 400-T18-080 | In distribution | |
| 270-120-130-L | In distribution | |
| 280-150-W30 | In distribution | |
| 400-T18-140 | In distribution | |
| 170-100-050-L | In distribution | |
| 401-T50-080 | In distribution |
Showing 250 of 300 catalogue numbers.
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
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-01-28 | Not classified | Device Design | The recall was initiated after Alphatec Spine received a complaint on the ILLICO Posterior Thoracolumbar access retractor. It was reported that one of the retractor arms in the retractor broke during surgery. | 14 | 2009-12-22 |
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.