Data / Medical devices / United States / SportCare

SportCare: FDA-registered device maker in Hidalgo, TX, United States, 3 510(k) clearances

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

SportCare is registered with the FDA (registration 3032314868) in Hidalgo, TX, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 2, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3032314868
Address: 700 east Produce Rd, Hidalgo, TX, United States, 78557
Owner or operator: Orthodoxo LLC (10091371)
Roles: Specification developer
First device listed: September 9, 2024
Registered through: 2026
Brand names listed: AnchorFix Knotless P+P, AnchorFix Knotless P+T, AnchorFix Pk, AnchorFix Soft, AnchorFix Ti, ArthroRazor Blade, ArthroRazor Bur, ArthroScrew BIO and more

Devices it lists

Device	Product code	Class	Role	Source
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Specification developer	accessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Specification developer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Specification developer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	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 2, 2024	K233601	Fixone Meniscal Repair	MBI	Substantially Equivalent	Aju Pharm Co., Ltd.	accessdata.fda.gov
December 25, 2021	K203523	Fixone hybrid knotless anchor	MAI	Substantially Equivalent	Aju Pharm Co., Ltd.	accessdata.fda.gov
January 5, 2021	K193497	Fixone Biocomposite Interference Screw	HWC	Substantially Equivalent	Aju Pharm Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 2, 2024. 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.