Data / Medical devices / Italy / Medicalplastic

Medicalplastic: FDA-registered device maker in MILANO Lombardy, Italy, 4 510(k) clearances

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

Medicalplastic is registered with the FDA (registration 9611863) in MILANO Lombardy, Italy. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 7, 2012. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9611863
FEI number: 3002807648
Address: Via Mercadante 15, MILANO Lombardy, Italy, 20124
Owner or operator: MEDICALPLASTIC (8021067)
Roles: Specification developer
First device listed: June 15, 1999
Registered through: 2026
Brand names listed: ILIZAROV, Ilizarov

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Specification developer	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	LXT	2	Specification developer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Specification developer	accessdata.fda.gov
Pin, Fixation, Threaded	JDW	2	Specification developer	accessdata.fda.gov
Software For Diagnosis/Treatment	OSN	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
June 7, 2012	K120871	SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION	JDW	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
September 27, 2010	K093047	SMITH & NEPHEW CIRCULAR FIXATION SYSTEM	KTT	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
February 18, 2000	K994143	SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]	JDW	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
March 19, 1987	K870961	RICHARDS EXTERNAL FIXATION SYSTEM	KTT	Substantially Equivalent	Richards Medical Co., Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 17, 2021	88785	Class II	Ongoing	Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434	Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due to a manufacturing error. An internal washer of the Ilizarov Wire Tensioner has been made in a wrong plastic material that could wear and break during the sterilization process in autoclave. Consequently this could cause malfunctioning of the tensio	accessdata.fda.gov

Compare with other makers

Updated June 7, 2012. 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.