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Shanghai Reach Medical Instrument Co., Ltd: FDA-registered device maker in Shanghai, China, 3 510(k) clearances

Name: Shanghai Reach Medical Instrument Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shanghai Reach Medical Instrument Co., Ltd is registered with the FDA (registration 3015487912) in Shanghai, China. It lists 30 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 29, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015487912
Address: Building 13, No.999 Jiangyue Road, Minhang District, Shanghai, China, 201114
Owner or operator: Shanghai REACH Medical Instrument Co., Ltd (10060472)
Roles: Manufacturer
First device listed: May 15, 2019
Registered through: 2026
Brand names listed: +Hex Screw Driver/Tab Counter Torque/Set Screw Driver+Torx Driver(short)/Set Screw Driver+Torx Driver(Long), Bench Clamp/Blade Distractor, Blade Breaking Wrench/Rod Rotate Wrench/Screw Conversion Wrench/Torx Locking Wrench (Long)/Screw Counter Torque, Bone Cutter(10), Bone Grafting/Graft Impactor (1/2)/Bone Graft Funnel(1/2)/Bone Graft Case(1/2/3)/Graft Impactor(1/2/3), Bone Impactor 2/Hand hammer 1/Slide hammer/Hammer/Cage deepening/Bone Impactor/Bone Impactor (S)/Bone Impactor (L), Bone Location Pin (90) / Bone Location Pin (110) / Bone Location Pin (130) / Bone Location Pin (150), Bone cement injector I/Bone cement injector II/Bone cement injector III/Bone cement injector IV and more

Devices it lists

Device	Product code	Class	Role	Source
Awl	HWJ	1	Manufacturer	accessdata.fda.gov
Bender	HXW	1	Manufacturer	accessdata.fda.gov
Brace, Drill	HXY	1	Manufacturer	accessdata.fda.gov
Curette	HTF	1	Manufacturer	accessdata.fda.gov
Cutter, Wire	HXZ	1	Manufacturer	accessdata.fda.gov
File	HTP	1	Manufacturer	accessdata.fda.gov
Forceps, Wire Holding	HYA	1	Manufacturer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Manufacturer	accessdata.fda.gov
Holder, Needle; Orthopedic	HXK	1	Manufacturer	accessdata.fda.gov
Impactor	HWA	1	Manufacturer	accessdata.fda.gov
Injector, Vertebroplasty (Does Not Contain Cement)	OAR	1	Manufacturer	accessdata.fda.gov
Instrument, Compression	HWN	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Pliers, Surgical	HTC	1	Manufacturer	accessdata.fda.gov
Positioner, Socket	KIL	1	Manufacturer	accessdata.fda.gov
Probe	HXB	1	Manufacturer	accessdata.fda.gov
Pusher, Socket	HXO	1	Manufacturer	accessdata.fda.gov
Reamer	HTO	1	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Scrapper, Skin Specimen	LXK	1	Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer	accessdata.fda.gov
Stripper, Surgical	HRT	1	Manufacturer	accessdata.fda.gov
Tap, Bone	HWX	1	Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov
Wrench	HXC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 29, 2023	K232069	Expandable Lumbar Fusion Cage (Type I,Type II)	MAX	Substantially Equivalent	Shanghai Reach Medical Instrument Co, Ltd.	accessdata.fda.gov
August 31, 2022	K221745	Sterile Posterior Spinal Fixation System	NKB	Substantially Equivalent	Shanghai Reach Medical Instrument Co, Ltd.	accessdata.fda.gov
June 21, 2021	K201737	Posterior Spinal Fixation System	NKB	Substantially Equivalent	Shanghai Reach Medical Instrument Co, Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 29, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.