Medtronic Reusable Instruments
TUBE RETRACTOR EX1221051 26mm W/45A^° 4cm
34manufacturers in China registered for this device type
891catalogue numbers in this listing
1510(k) clearance
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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | GAD |
| Device type | Retractor |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2022-10-07 |
| Record revised | 2026-03-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Sizes | Outer diameter 6.7 to 12 mm |
| Distribution end date | 2026-04-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X0819080 | In distribution | |
| EX0412187 | In distribution | |
| EX0513068 | In distribution | |
| EX0218023 | In distribution | |
| EX0920046 | In distribution | |
| X07311115 | In distribution | |
| EX0412183 | In distribution | |
| EX0511177 | In distribution | |
| X9560554 | In distribution | |
| EX0213102 | In distribution | |
| X0199-026 | In distribution | |
| X07212281 | In distribution | |
| EX02121231 | In distribution | |
| X07311054 | In distribution | |
| X07311044 | In distribution | |
| EX0823280 | In distribution | |
| X0819100 | In distribution | |
| EX1221051 | In distribution | |
| X07314111 | In distribution | |
| EX0823150 | In distribution | |
| X07314110 | In distribution | |
| EX0519024 | In distribution | |
| X0819060 | In distribution | |
| EX0410042 | In distribution | |
| X0819090 | In distribution | |
| EX0621010 | In distribution | |
| EX0226170 | In distribution | |
| EX06123989 | In distribution | |
| X07318262 | In distribution | |
| 9198421 | In distribution | |
| EX1221050 | In distribution | |
| X07212191 | In distribution | |
| EX0410043 | In distribution | |
| X07211170 | In distribution | |
| EX0512307 | In distribution | |
| EX0118024 | In distribution | |
| X07212002 | In distribution | |
| X07314190 | In distribution | |
| EX0418047 | In distribution | |
| 9560216 | In distribution | |
| EX0613160 | In distribution | |
| X07318809 | In distribution | |
| EX0519050 | In distribution | |
| X07214151 | In distribution | |
| X07211150 | In distribution | |
| X07312085 | In distribution | |
| EX02121232 | In distribution | |
| X07314171 | In distribution | |
| X07314150 | In distribution | |
| X0916061 | In distribution | |
| X07317172 | In distribution | |
| 9560731 | In distribution | |
| X07311095 | In distribution | |
| 892.606 | In distribution | |
| X07318162 | In distribution | |
| EX0913006 | In distribution | |
| EX0226080 | In distribution | |
| X0711476 | In distribution | |
| X07317131 | In distribution | |
| EX0512223 | In distribution | |
| EX0920042 | In distribution | |
| EX0112039 | In distribution | |
| EX0621011 | In distribution | |
| EX1221040 | In distribution | |
| X0512170 | In distribution | |
| EX0313110 | In distribution | |
| X0808141 | In distribution | |
| EX0226070 | In distribution | |
| X07311091 | In distribution | |
| EX0512220 | In distribution | |
| EX0711565 | In distribution | |
| EX0313372 | In distribution | |
| EX0114090 | In distribution | |
| EX0513064 | In distribution | |
| EX0412185 | In distribution | |
| EX0512263 | In distribution | |
| EX0221015 | In distribution | |
| X0506315 | In distribution | |
| X0512166 | In distribution | |
| EX0418038 | In distribution | |
| X1119020 | In distribution | |
| X0512110 | In distribution | |
| X0517074 | In distribution | |
| EX0421022 | Outer Diameter 12.0 mm | In distribution |
| X0711485 | In distribution | |
| X07311130 | In distribution | |
| EX0311383 | In distribution | |
| X07211031 | In distribution | |
| X0318044 | In distribution | |
| X0411204 | In distribution | |
| EX0111106 | In distribution | |
| EX0923001 | In distribution | |
| EX0410377 | In distribution | |
| X07210001 | In distribution | |
| EX1013240 | In distribution | |
| X0701018 | In distribution | |
| X07314132 | In distribution | |
| EX0313109 | In distribution | |
| X0814151 | In distribution | |
| X07318382 | In distribution | |
| EX1117067 | In distribution | |
| EX1221056 | In distribution | |
| X07211020 | In distribution | |
| EX0114075 | In distribution | |
| X0299-035 | In distribution | |
| X07210002 | In distribution | |
| X07312191 | In distribution | |
| X1205219 | In distribution | |
| X07312192 | In distribution | |
| EX0511179 | In distribution | |
| X07318163 | In distribution | |
| EX0910033 | In distribution | |
| X07311155 | In distribution | |
| X07312002 | In distribution | |
| EX02121233 | In distribution | |
| X07311058 | In distribution | |
| X0512151 | In distribution | |
| EX0120031 | In distribution | |
| X07210004 | In distribution | |
| X0925008 | In distribution | |
| EX0512217 | In distribution | |
| X07318197 | In distribution | |
| X07211023 | In distribution | |
| EX0519027 | In distribution | |
| X0512136 | In distribution | |
| X0218028 | In distribution | |
| X0814153 | In distribution | |
| EX0114086 | In distribution | |
| X07318117 | In distribution | |
| EX0418035 | In distribution | |
| X07311030 | In distribution | |
| EX0910036 | In distribution | |
| EX0920044 | In distribution | |
| X0512153 | In distribution | |
| EX1213009 | In distribution | |
| EX0620023 | In distribution | |
| X07311190 | In distribution | |
| X07318715 | In distribution | |
| EX0418036 | In distribution | |
| X07318263 | In distribution | |
| X1004816 | In distribution | |
| EX0412186 | In distribution | |
| EX0226160 | In distribution | |
| X07312010 | In distribution | |
| EX0311094 | In distribution | |
| EX1221048 | In distribution | |
| X1205218 | In distribution | |
| EX0512306 | In distribution | |
| EX06123980 | In distribution | |
| EX0411173 | In distribution | |
| X0196-526R | In distribution | |
| X07318177 | In distribution | |
| X07318170 | In distribution | |
| X07214150 | In distribution | |
| X07317170 | In distribution | |
| X0512141 | In distribution | |
| X0798-013 | In distribution | |
| 9565006 | In distribution | |
| X07318098 | In distribution | |
| EX0313374 | In distribution | |
| X07214152 | In distribution | |
| EX1012107 | In distribution | |
| X1103089L | In distribution | |
| X0814152 | In distribution | |
| EX0418025 | In distribution | |
| X07210003 | In distribution | |
| X07311048 | In distribution | |
| X0711478 | In distribution | |
| EX0113014 | In distribution | |
| EX0311386 | In distribution | |
| X07311171 | In distribution | |
| X0814161 | In distribution | |
| EX0418048 | In distribution | |
| EX0114085 | In distribution | |
| X0818060 | In distribution | |
| X07317130 | In distribution | |
| X07214192 | In distribution | |
| X8369001 | In distribution | |
| EX0226050 | In distribution | |
| 955-524 | In distribution | |
| EX1221043 | In distribution | |
| X07317190 | In distribution | |
| X07213191 | In distribution | |
| EX0823140 | In distribution | |
| X07318182 | In distribution | |
| X07318815 | In distribution | |
| X0916059 | In distribution | |
| EX0421023 | Outer Diameter 6.7 mm | In distribution |
| X0525002 | In distribution | |
| X1218017 | In distribution | |
| X07212001 | In distribution | |
| EX1221057 | In distribution | |
| X07318817 | In distribution | |
| EX0313113 | In distribution | |
| EX1213006 | In distribution | |
| X1103089R | In distribution | |
| X0798-005 | In distribution | |
| X0814158 | In distribution | |
| X0808136 | In distribution | |
| X0603554 | In distribution | |
| X0512148 | In distribution | |
| X07214190 | In distribution | |
| X07311021 | In distribution | |
| X07213172 | In distribution | |
| X0916065 | In distribution | |
| X07314000 | In distribution | |
| X0512159 | In distribution | |
| X0116007 | In distribution | |
| X0512163 | In distribution | |
| X07213131 | In distribution | |
| EX0118031 | In distribution | |
| X07311008 | In distribution | |
| EX1012275 | In distribution | |
| EX0621016 | In distribution | |
| EX0118030 | In distribution | |
| EX0724002 | In distribution | |
| X07318363 | In distribution | |
| X07310102 | In distribution | |
| EX06123974 | In distribution | |
| EX0921001 | In distribution | |
| EX1221052 | In distribution | |
| EX0823170 | In distribution | |
| EX0618060 | In distribution | |
| EX1213008 | In distribution | |
| EX0519016 | In distribution | |
| X07310100 | In distribution | |
| X07317110 | In distribution | |
| EX0213139 | In distribution | |
| EX0412184 | In distribution | |
| X0818100 | In distribution | |
| EX0518013 | In distribution | |
| X0603555 | In distribution | |
| X07318004 | In distribution | |
| X07318190 | In distribution | |
| EX0610210 | In distribution | |
| X07212082 | In distribution | |
| X0805073 | In distribution | |
| X0702011 | In distribution | |
| X07213190 | In distribution | |
| X07311150 | In distribution | |
| 2670006 | In distribution | |
| EX1117066 | In distribution | |
| X0506316 | In distribution | |
| EX0418030 | In distribution | |
| EX1221047 | In distribution | |
| X07318183 | In distribution | |
| EX0519014 | In distribution | |
| X0814155 | In distribution | |
| EX0114087 | In distribution | |
| X07211004 | 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 |
| Boss Instruments | Boss Instruments, Ltd. | 799 |
| gSource | Gsource, LLC. | 753 |
| Sklar® | Sklar Corporation | 753 |
| Ambler Surgical | Ambler Surgical, LLC | 744 |
Showing 12 of 2,238. All products under Retractor
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K043602 | 2005-02-23 |
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.