Data / Medical devices / Applier, Cerclage

Applier, Cerclage (HXN): 22 FDA-registered makers in 5 countries

Name: FDA-registered makers of Applier, Cerclage
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

22 establishments in 5 countries are registered with the FDA to make Applier, Cerclage (product code HXN, Class 1, 21 CFR 888.4540). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on January 23, 2003, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: HXN
Device class: 1
Regulation: 888.4540
Medical specialty: Orthopedic

Makers by country

Country	Makers
United States	7
Germany	7
India	4
China	3
Pakistan	1

Makers of Applier, Cerclage

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Source
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	1	January 23, 2003	api.fda.gov
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Manufacturer	0		api.fda.gov
Asanus Medizintechnik GMBH	NEUHAUSEN OBECK Baden-Wurttemberg, Germany	Manufacturer, Repackager or relabeler, Specification developer	0		api.fda.gov
B.Braun Medical (Suzhou) Co,.Ltd	Suzhou Jiangsu, China	Contract manufacturer	0		api.fda.gov
CM Instrumente GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		api.fda.gov
Dimeda Instrumente GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0		api.fda.gov
Greens Surgicals Private Limited	Vadodara Gujarat, India	Manufacturer	0		api.fda.gov
Hospital Equipment MFG. Co.	NOIDA Uttar Pradesh, India	Manufacturer	0		api.fda.gov
Med2b Ltd.	Kitzingen Bavaria, Germany	Manufacturer	0		api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Repackager or relabeler, Specification developer	0		api.fda.gov
Narang Medical, Ltd.	New Delhi, India	Manufacturer	0		api.fda.gov
Osseus Fusion Systems LLC	Dallas, TX, United States	Repackager or relabeler, Specification developer	0		api.fda.gov
Pioneer Surgical Technology, Inc.	Marquette, MI, United States	Manufacturer	0		api.fda.gov
Rudolf Medical GMBH + Co. KG	FRIDINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.	Shanghai, China	Manufacturer	0		api.fda.gov
Solco Biomedical Company India Private Limited	KADI Gujarat, India	Contract manufacturer, Manufacturer	0		api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Manufacturer	0		api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Complaint file establishment, Specification developer	0		api.fda.gov
Xinhua Surgical Instrument Co. Ltd.	ZIBO Shandong, China	Manufacturer	0		api.fda.gov
Zepf Medical Instruments GMBH	SEITINGEN-OBERFLACHT Baden-Wurttemberg, Germany	Manufacturer	0		api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer, Repackager or relabeler	0		api.fda.gov

Updated January 23, 2003. 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.