Shanghai Reach Medical Instrument Co., Ltd.
Manufacturer and brand owner in Shanghai, China. 30 device types, 2 products catalogued, 3 clearances.
Shanghai Reach Medical Instrument Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Awl, File and 28 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2019.
30device types registered with the FDA
2products catalogued under its own name
3510(k) clearances
Registration
| Registered name | SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015487912 |
| FEI number | 3015487912 |
| DUNS | 530695344 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 上海锐植医疗器械有限公司 |
|---|---|
| Unified social credit code | 913101127851603452 |
| Source | NMPA UDI database |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Building 13, No.999 Jiangyue Road, Minhang District |
| Postal code | 201114 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Awl | Class 1 | Disposable Bone Access Tool/Cannulated Awl/Straight Pedicle Finder/Curved Pedicle Finder /Thoracic Vertebra Awl, Pedicle Finder/Pedicle Finder-straight(Lumbar)/Pedicle Finder-straight(thoracic), Pedicle Finder-curved/Awl/Awl(with handle) | 2021 | 13 |
| Bender | Class 1 | Coronal rod bender-right/ Plate Bender, Rod bender/Sagittal rod bender-Left/Sagittal rod bender-Right/Coronal rod bender-left, Rod Bender 325/Sagittal Bar Bender L/Sagittal Bar Bender R/Coronal Bar Bender L/Coronal Bar Bender R | 2021 | 10 |
| Brace, Drill | Class 1 | Drill /4 Drill/4 Adjustable Drill/4.5 Drill/Adjustable Drill Stop/Steering Drill/Universal Drill | 2021 | 5 |
| Curette | Class 1 | Cervical curette1/2/3/4 /Angled Curette(straight/left/right)/Toothed curette (straight/left/right), Curette (S)/Curette (M)/Curette (L), Circular Curette (with teeth) / Curette (90°), Distraction paddle(7/8/9/10/11/12/13/14) | 2021 | 11 |
| Cutter, Wire | Class 1 | Bone Cutter(10), Rod cutter | 2021 | 10 |
| File | Class 1 | File/Cervical fusion cage file | 2021 | 9 |
| Forceps, Wire Holding | Class 1 | Set Screw Holder/Rod Holder(L)/Crosslink Holder, Cap Holder, Plate Holder/Screw Holder/Cage holder/Nucleus pulposus forceps (straight 220x3mm), Rod Holder/L-Rod Holder/Rod Holder/Powerful Rod Holder/Rocker/Rod Reductor 6/Crosslink Holder, Cage holder & retension rod | 2021 | 8 |
| Guide, Needle, Surgical | Class 1 | Bone Location Pin (90) / Bone Location Pin (110) / Bone Location Pin (130) / Bone Location Pin (150), Variable Angle Drill Guide/ Fixed Angle Dual Drill Guide, Guider (Round)/ Circular Position Needle/ Cylindrical Position Needle/ Plate Holding Pin/ Fixed Angle Drill Gudie, Jamshidi Needle, K-Wire/Guide Needle/Ball Locating Pin/Cylindrical Locating Pin, Pointed Guide Wire/Guide Wire | 2021 | 32 |
| Holder, Needle; Orthopedic | Class 1 | Puncture needle | 2021 | 15 |
| Impactor | Class 1 | Impactor, Slap Hammer, Bone Impactor 2/Hand hammer 1/Slide hammer/Hammer/Cage deepening/Bone Impactor/Bone Impactor (S)/Bone Impactor (L) | 2021 | 18 |
| Injector, Vertebroplasty (Does Not Contain Cement) | Class 1 | Bone cement injector I/Bone cement injector II/Bone cement injector III/Bone cement injector IV | 2021 | 5 |
| Instrument, Compression | Class 1 | Compression Plier/Support block/Parallel Distractor/Distractor 1/Distractor 2/Distractor(right)/Distractor(left), Distractor/Distractor-with handle7/8/9/10/11/12/13/14/Distractor rod 7/8/9/10/11/12/13/14/Spinous process distractor, Two-way Distractor/Distractor & Compressor/Compressor | 2021 | 8 |
| Instrument, Manual, Surgical, General Use | Class 1 | Expansion Sleeve (?5) / Expansion Sleeve (?10.5) / Expansion Sleeve (?16) / Expansion Sleeve (?20.7), Dilator 6/Dilator 13/Dilator 14.5/Dilator 16.2/Outer Tube/Inner Tube/Rod Reductor, Free Arm, Dilator/Single Use Cannula/Persuader Sleeve | 2021 | 110 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | Class 2 | F0301-B0024AC6C,24*10*12*6-12°; F0301-B0024AC6F,24*10*12*6-15°; F0301-B0024AD43,24*10*13*4-3°;, F0301-B0028AB6C,28*10*11*6-12°; F0301-B0028AB6F,28*10*11*6-15°; F0301-B0028AC43,28*10*12*4-3°;, F0301-B0024CH46,24*12*17*4-6°; F0301-B0024CH49,24*12*17*4-9°; F0301-B0024CH4C,24*12*17*4-12°;, F0301-B0028CA4F,28*12*10*4-15°; F0301-B0028CA53,28*12*10*5-3°; F0301-B0028CA56,28*12*10*5-6°;, F0301-B0028CB63,28*12*11*6-3°; F0301-B0028CB66,28*12*11*6-6°; F0301-B0028CB69,28*12*11*6-9°;, F0301-B0032AG6F,32*10*16*6-15°; F0301-B0032AH43,32*10*17*4-3°; F0301-B0032AH46,32*10*17*4-6°; and 54 more | 2023 | 14 |
| Kit, Surgical Instrument, Disposable | Class 1 | Disposable spinal fixation instrument set, Cervical Plate System Instrument Set/Cervical Interbody Fusion Cage Instrument Set, Posterior Spinal Fixation System Instrument Set/Expandable Lumbar Fusion Cage Instrument Set | 2019 | 67 |
| Orthopedic Manual Surgical Instrument | Class 1 | Bone Grafting/Graft Impactor (1/2)/Bone Graft Funnel(1/2)/Bone Graft Case(1/2/3)/Graft Impactor(1/2/3), Funnel with extension, Persuader, Funnel(S) | 2021 | 53 |
| Pliers, Surgical | Class 1 | Distractor Plier | 2021 | 11 |
| Positioner, Socket | Class 1 | Safety Stopper | 2024 | 4 |
| Probe | Class 1 | Probe/Probe (Straight), Straight Probe/Double-headed Probe | 2021 | 12 |
| Pusher, Socket | Class 1 | Rod Pusher | 2021 | 6 |
| Reamer | Class 1 | Reamer (sheet) 6/7/8/9/10/11/12 /13/14/15/16 / Reamer (sheet)-with handle 6/7/8/9/10/11/12/13/14/15 /16, Hollow intervertebral disc reamer(small/Medium/ Large)/Reamer adjustable (9/10/11/12/13/14), Reamer (round)-with handle 6/7/8/9/10/11/12/13/14/15/16 / Reamer rod 6/7/8/9/10/11/12/13/14/15/16, Shaver(6/7/8/9/10/11/12/13/14), Reamer(8) / Reamer(10) / Reamer(12) / Reamer(14) | 2021 | 23 |
| Retractor | Class 1 | Retractor(large)/Retractor(small), Vertebral Retractor | 2021 | 34 |
| Scrapper, Skin Specimen | Class 1 | Square Scraper(straight)/Square scraper (curved)/Tear-drop Scraper(straight/left/right), End plate scraper (small/medium/large), Scraper | 2021 | 4 |
| Screwdriver | Class 1 | Cage Driver/Cage Driver(AO)/Holder Shaft1, Ratchet Handle/Oval Handle/Crosslink Inner Hex Driver/2in1 Polyaxial screw driver, Expanded Blade (90) / Expanded Blade (110) /, Offset Spanner+Set Screw Holder (long)/T Handle/T Ratchet Handle, Expanded Blade (130) / Expanded Blade (150), Crosslink Hex Driver/ Dual-purpose screwdriver/Distraction Screw/Mark pin Handle/Cage Holder 1/Handle/Torx Driver and 12 more | 2021 | 18 |
| Stripper, Surgical | Class 1 | Periosteum Separator (10) / Periosteum Separator (18), Detacher (1/2/3/4/5/6) | 2021 | 7 |
| Tap, Bone | Class 1 | Cannulated Screw Tap 5/Cannulated Screw Tap 6 /Screw Tap 4/Screw Tap 5 / Screw Tap 6, Screw Tap ?4/Screw Tap ?5/Screw Tap ?6/Screw Tap ?7/4 Adjustable Cancellous Tap, Tap for Cannulated Screws ?5.5/Tap for CannulatedScrews ?6/Tap for CannulatedScrews ?6.5, Canulated Screw Tap 4.5/Canulated Screw Tap 5.5/Canulated Screw Tap 6.5/Screw Tap 4.5/Screw Tap 5.5/Screw Tap 6.5 | 2021 | 12 |
| Tape, Measuring, Rulers And Calipers | Class 1 | Trial(7.6×45) / Trial(7.6×50) / Trial(7.6×55) / Trial(11×45) / Trial(11×50), Trial(11×55) / Trial(13×45) / Trial(13×50) / Trial(13×55), Rod Measure/depth-measure/Plate Measure/Test Rod, Trial(7/8/9/10/11/12/13/14)/Trial Rod(7/8/9/10/11/12/13/14), Trial 4/Trial 5/Trial 6/Trial 7/Trial 8/Trial 4(Without handle)/Trial 5(Without handle)/Trial 6 (Without handle)/, Trial 7(Without handle)/Trial 8(Without handle)/Trial(7/8/9/10/11/12/13/14)(With handle)/ and 1 more | 2021 | 42 |
| Thoracolumbosacral Pedicle Screw System | Class 2 | Sterile Posterior Spinal Fixation System, Posterior Spinal Fixation System | 2021 | 15 |
| Tray, Surgical, Instrument | Class 1 | Sterilization Case, Screw plug box/Instrument box/Screw Cross Link Box/Implant box (plate, screw)/Tool box/partition/Expandable Cage case, Sterilization box (L)/Sterilization box (S), Set Screw Case | 2021 | 105 |
| Wrench | Class 1 | Torx Wrench/Torx Locking Wrench / Counter Torque Wrench/Tap Breaker/Wrench/Torque Wrench/Screw Counter Wrench, Torx Locking Wrench, Hook Blade (90) / Hook Blade (110) / Hook Blade (130) / Hook Blade (150), Cannulate Conversion Wrench + Hexagonal Wrench, Blade Breaking Wrench/Rod Rotate Wrench/Screw Conversion Wrench/Torx Locking Wrench (Long)/Screw Counter Torque, T Hexagonal Wrench | 2026 | 14 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Sterile Posterior Spinal Fixation System | NKB | 107 |
| Expandable Lumbar Fusion Cage-Type I | MAX | 15 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232069 | 2023-11-29 | MAX | Traditional | This company |
| K221745 | 2022-08-31 | NKB | Special | This company |
| K201737 | 2021-06-21 | NKB | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Main products | Spine implants, Orthopedic implants, Surgical instruments |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.