Data / Medical devices / United States / Fusionx Medtech Inc.

Fusionx Medtech Inc.: FDA-registered device maker in Whittier, CA, United States, 2 510(k) clearances

Name: Fusionx Medtech Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Fusionx Medtech Inc. is registered with the FDA (registration 3047889355) in Whittier, CA, United States. It lists 22 device types. The FDA files 2 510(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: 3047889355
Address: 8108 San Lucas Dr, Whittier, CA, United States, 90605
Owner or operator: FusionX MedTech Inc. (10096064)
Roles: Repackager or relabeler
First device listed: June 16, 2026
Registered through: 2026
Brand names listed: Awl/Cannulated Awl, Bench Clamp/Blade Distractor, Blade Breaking Wrench/Rod Rotate Wrench, Bone Location Pin (130) / Bone Location Pin (150), Bone Location Pin (90) / Bone Location Pin (110) /, Cage Driver/Cage Driver(AO)/Holder Shaft1/, Cage holder/, Cannulate Conversion Wrench + Hexagonal Wrench/ and more

Devices it lists

Device	Product code	Class	Role	Source
Awl	HWJ	1	Repackager or relabeler	accessdata.fda.gov
Bender	HXW	1	Repackager or relabeler	accessdata.fda.gov
Curette	HTF	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Wire Holding	HYA	1	Repackager or relabeler	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Repackager or relabeler	accessdata.fda.gov
Impactor	HWA	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Compression	HWN	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Repackager or relabeler	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Repackager or relabeler	accessdata.fda.gov
Probe	HXB	1	Repackager or relabeler	accessdata.fda.gov
Pusher, Socket	HXO	1	Repackager or relabeler	accessdata.fda.gov
Reamer	HTO	1	Repackager or relabeler	accessdata.fda.gov
Retractor	GAD	1	Repackager or relabeler	accessdata.fda.gov
Scrapper, Skin Specimen	LXK	1	Repackager or relabeler	accessdata.fda.gov
Screwdriver	HXX	1	Repackager or relabeler	accessdata.fda.gov
Stripper, Surgical	HRT	1	Repackager or relabeler	accessdata.fda.gov
Tap, Bone	HWX	1	Repackager or relabeler	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Repackager or relabeler	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Repackager or relabeler	accessdata.fda.gov
Wrench	HXC	1	Repackager or relabeler	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
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.