Data / Medical devices / Belgium / Orfit Industries NV

Orfit Industries NV: FDA-registered device maker in WIJNEGEM Antwerpen, Belgium, 13 510(k) clearances

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

Orfit Industries NV is registered with the FDA (registration 9613183) in WIJNEGEM Antwerpen, Belgium. It lists 16 device types. The FDA files 13 510(k) clearances under its listings, the newest dated August 14, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9613183
FEI number: 1000227792
Address: 9a, Vosveld, WIJNEGEM Antwerpen, Belgium, B-2110
Owner or operator: ORFIT INDUSTRIES NV (9015000)
Roles: Contract manufacturer, Manufacturer
First device listed: August 7, 1996
Registered through: 2026
Brand names listed: 43450 - CRANIAL 4PI STEREOTACTIC MASK (5PCS.), 43450A - CRANIAL 4PI STEREOTACTIC MASK (5PCS.), 43451 - CRANIAL 4PI BASIC MASK (5 PCS.), 43451A - CRANIAL 4PI BASIC MASK (5 PCS.), 43453 - CRANIAL 4PI EXTENDED MASK (5 PCS.), 4352 - CRANIAL 4PI OPEN FACE MASK (5PCS.), 4352A - CRANIAL 4PI OPEN FACE MASK (5PCS.), 43610 - Frameless SRS MASK SET CRANIAL (5 PCS.), 49660 - Frameless SRS MASK SET EXTENDED (5 PCS.) and more

Devices it lists

Device	Product code	Class	Role	Source
Accelerator, Linear, Medical	IYE	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Component, Cast	LGF	1	Manufacturer	accessdata.fda.gov
Component, External, Limb, Ankle/Foot	ISH	1	Manufacturer	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Manufacturer	accessdata.fda.gov
Orthosis, Lumbar	IQE	1	Manufacturer	accessdata.fda.gov
Orthosis, Moldable, Supportive, Skin Protective	MNE	1	Manufacturer	accessdata.fda.gov
Orthosis, Truncal/Orthosis, Limb	MRI	1	Manufacturer	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Manufacturer	accessdata.fda.gov
Splint, Hand, And Components	ILH	1	Manufacturer	accessdata.fda.gov
Splint, Nasal	EPP	1	Manufacturer	accessdata.fda.gov
Stirrup, External Brace Component	ITC	1	Manufacturer	accessdata.fda.gov
Surgical Table Cushion	LWG	1	Manufacturer	accessdata.fda.gov
System, Radiation Therapy, Charged-Particle, Medical	LHN	2	Manufacturer	accessdata.fda.gov
Table, Radiologic	KXJ	2	Manufacturer	accessdata.fda.gov
Twister, Brace Setting	ITO	1	Manufacturer	accessdata.fda.gov
Warmer, Irrigation Solution	LHC	1	Manufacturer	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 14, 2020	K202068	The AIO Solution 3.0	IYE	Substantially Equivalent	Orfit Industries NV	accessdata.fda.gov
April 8, 2020	K200282	Orfit Aerial Couchtop	LHN	Substantially Equivalent	Orfit Industries NV	accessdata.fda.gov
August 6, 2019	K191158	The AIO Solution	IYE	Substantially Equivalent	Orfit Industries NV	accessdata.fda.gov
July 25, 2017	K171734	HP PRO Positioning Device	IYE	Substantially Equivalent	Orfit Industries NV	accessdata.fda.gov
November 22, 2016	K162355	Raycast MammoRx Carbon Fibre Breast Board	IYE	Substantially Equivalent	Orfit Industries NV	accessdata.fda.gov
November 9, 2016	K162862	Raycast High Precision Lung Board Solution	IYE	Substantially Equivalent	Orfit Industries NV	accessdata.fda.gov
November 9, 2015	K151946	Thermofit	IYE	Substantially Equivalent	Orfit Industries	accessdata.fda.gov
July 28, 2015	K151207	Proton Immobilization Solution	IYE	Substantially Equivalent	Orfit Industries NV	accessdata.fda.gov
August 7, 2014	K141787	SAGITTILT	IYE	Substantially Equivalent	Orfit Industries NV	accessdata.fda.gov
September 26, 2013	K131795	NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS	IYE	Substantially Equivalent	Orfit Industries NV	accessdata.fda.gov
May 23, 2005	K050888	INTEGRA IMMOBILIZATION SYSTEM	IYE	Substantially Equivalent	Diacor, Inc.	accessdata.fda.gov
September 21, 1999	K991319	RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS	IYE	Substantially Equivalent	Orfit Industries	accessdata.fda.gov
July 26, 1993	K930246	MAMMORX	IYE	Substantially Equivalent	Diacor, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 14, 2020. 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.