Data / Medical devices / United States / Topmed Medical Devices Inc

Topmed Medical Devices Inc: FDA-registered device maker in Irvine, CA, United States, 2 510(k) clearances

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

Topmed Medical Devices Inc is registered with the FDA (registration 3039169546) in Irvine, CA, United States. It lists 16 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 31, 2022. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3039169546
Address: 16 Goddard, Irvine, CA, United States, 92618
Owner or operator: Topmed Medical Devices Inc (10093458)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: June 22, 2025
Registered through: 2026
Brand names listed: 2in1 Polyaxial screw driver, Awl, BLADE, Ball Locating Pin, Blade Breaking Wrench, Cannulate Conversion Wrench + Hexagonal Wrench, Cannulated Awl, Cannulated Screw Tap 5 and more

Devices it lists

Device	Product code	Class	Role	Source
Awl	HWJ	1	Complaint file establishment	accessdata.fda.gov
Bender	HXW	1	Complaint file establishment	accessdata.fda.gov
Forceps, Wire Holding	HYA	1	Complaint file establishment	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Complaint file establishment	accessdata.fda.gov
Instrument, Compression	HWN	1	Complaint file establishment	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Complaint file establishment	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Complaint file establishment	accessdata.fda.gov
Motor, Surgical Instrument, Pneumatic Powered	GET	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Probe	HXB	1	Complaint file establishment	accessdata.fda.gov
Pusher, Socket	HXO	1	Complaint file establishment	accessdata.fda.gov
Reamer	HTO	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Screwdriver	HXX	1	Complaint file establishment	accessdata.fda.gov
Tap, Bone	HWX	1	Complaint file establishment	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Complaint file establishment	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Complaint file establishment	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Complaint file establishment	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
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 August 31, 2022. 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.