Data / Medical devices / United States / Surgtech, Inc.

Surgtech, Inc.: FDA-registered device maker in Westlake, OH, United States, 6 510(k) clearances

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

Surgtech, Inc. is registered with the FDA (registration 3011170410) in Westlake, OH, United States. It lists 10 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 1, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011170410
Address: 24600 Center Ridge Road, Suite 195, Westlake, OH, United States, 44145
Owner or operator: SurgTech, Inc. (10047514)
Roles: Manufacturer, Specification developer
First device listed: June 1, 2016
Registered through: 2026
Brand names listed: SurgTech Bipolar, SurgTech Knee System, SurgTech Posterior Fusion, SurgTech TLS, SurgTech Total Hip, SurgTech Trauma Plates and Screws

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Manufacturer, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer, Specification developer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	2	Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	2	Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	2	Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Manufacturer, Specification developer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer, Specification developer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer, Specification developer	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 1, 2019	K191192	SurgTech GENOLL Total Knee System	JWH	Substantially Equivalent	Surgtech, Inc.	accessdata.fda.gov
June 14, 2018	K173455	SurgTech Bipolar Head System	KWY	Substantially Equivalent	Surgtech, Inc.	accessdata.fda.gov
May 10, 2017	K162125	MALUC Total Hip Arthroplasty System	JDI	Substantially Equivalent	Surgtech, Inc.	accessdata.fda.gov
April 5, 2017	K163363	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	NKB	Substantially Equivalent	Surgtech, Inc.	accessdata.fda.gov
February 21, 2017	K161894	SurgTech Trauma System	HWC	Substantially Equivalent	Surgtech, Inc.	accessdata.fda.gov
March 25, 2016	K152200	SurgTech Interbody System	MAX	Substantially Equivalent	Surgtech, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 1, 2019. 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.