Shanghai Reach Medical Instrument Co., Ltd
Shanghai, CN
SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD appears in FDA device records in Shanghai, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Shanghai Reach Medical Instrument Co., Ltd between 2021 and 2023. The busiest year on record is 2021, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232069 | Expandable Lumbar Fusion Cage (Type I,Type II) | MAX | Substantially Equivalent | |
| K221745 | Sterile Posterior Spinal Fixation System | NKB | Substantially Equivalent | |
| K201737 | Posterior Spinal Fixation System | NKB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015487912 | 3015487912 | SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD | Building 13, No.999 Jiangyue Road, Minhang District, Shanghai 201114 CN | 2026 | and 20 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HWJAwl
- HXWBender
- HXYBrace, Drill
- HTFCurette
- HXZCutter, Wire
- HTPFile
- HYAForceps, Wire Holding
- GDFGuide, Needle, Surgical
- HXKHolder, Needle; Orthopedic
- HWAImpactor
- OARInjector, Vertebroplasty (Does Not Contain Cement)
- HWNInstrument, Compression
- MDMInstrument, Manual, Surgical, General Use
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- KDDKit, Surgical Instrument, Disposable
- LXHOrthopedic Manual Surgical Instrument
- HTCPliers, Surgical
- KILPositioner, Socket
- HXBProbe
- HXOPusher, Socket
- HTOReamer
- GADRetractor
- LXKScrapper, Skin Specimen
- HXXScrewdriver
- HRTStripper, Surgical
- HWXTap, Bone
- FTYTape, Measuring, Rulers And Calipers
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain