Invictus
Decompression Tube, 22mm x 120mm
34manufacturers in China registered for this device type
50catalogue 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 | 2021-11-23 |
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 | Length 50 to 120 mm; outer diameter 18 to 26 mm; angle 30 to 60 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16187-26-90 | Length 90 mm | In distribution |
| 17197-22-120 | Length 120 mm | In distribution |
| 16187-22-80 | Outer Diameter 22 mm | In distribution |
| 17197-26-110 | Length 110 mm | In distribution |
| 16187-24-80 | Outer Diameter 24 mm | In distribution |
| 16187-18-80 | Outer Diameter 18 mm | In distribution |
| 16187-22-90 | Outer Diameter 22 mm | In distribution |
| 16187-20-90 | Outer Diameter 20 mm | In distribution |
| 17197-24-90 | Outer Diameter 24 mm | In distribution |
| CI-10043 | In distribution | |
| 17197-20-80 | Outer Diameter 20 mm | In distribution |
| 17197-22-110 | Outer Diameter 22 mm | In distribution |
| 16187-22-110 | Length 110 mm | In distribution |
| 17197-22-100 | Length 100 mm | In distribution |
| 17197-26-80 | Outer Diameter 26 mm | In distribution |
| 17868-00 | In distribution | |
| 17197-26-100 | Outer Diameter 26 mm | In distribution |
| 16187-24-70 | Outer Diameter 24 mm | In distribution |
| 17197-22-90 | Length 90 mm | In distribution |
| 16187-22-70 | Length 70 mm | In distribution |
| 16187-20-70 | Length 70 mm | In distribution |
| 16187-24-90 | Outer Diameter 24 mm | In distribution |
| 17197-26-70 | Length 70 mm | In distribution |
| 16187-22-60 | Length 60 mm | In distribution |
| 17197-20-70 | Outer Diameter 20 mm | In distribution |
| 17197-22-80 | Length 80 mm | In distribution |
| 16187-18-90 | Length 90 mm | In distribution |
| 17868-60 | Angle 60 ° | In distribution |
| 17197-26-60 | Length 60 mm | In distribution |
| 16187-26-70 | Length 70 mm | In distribution |
| 17197-20-90 | Length 90 mm | In distribution |
| 17197-26-90 | Length 90 mm | In distribution |
| 16187-22-100 | Length 100 mm | In distribution |
| 16187-22-120 | Outer Diameter 22 mm | In distribution |
| 17197-18-80 | Outer Diameter 18 mm | In distribution |
| 17197-24-80 | Outer Diameter 24 mm | In distribution |
| 16187-26-80 | Length 80 mm | In distribution |
| 17868-30 | Angle 30 ° | In distribution |
| 17197-22-50 | Length 50 mm | In distribution |
| 16188 | In distribution | |
| 16187-18-70 | Length 70 mm | In distribution |
| 17198 | In distribution | |
| 16187-20-80 | Length 80 mm | In distribution |
| 17197-22-70 | Outer Diameter 22 mm | In distribution |
| 17868-45 | Angle 45 ° | In distribution |
| 16187-22-50 | Length 50 mm | In distribution |
| 17197-22-60 | Length 60 mm | In distribution |
| 17197-18-70 | Outer Diameter 18 mm | In distribution |
| 17197-24-70 | Outer Diameter 24 mm | In distribution |
| 17197-18-90 | Outer Diameter 18 mm | 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
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.