Orfit Industries NV
WIJNEGEM Antwerpen, BE
ORFIT INDUSTRIES NV appears in FDA device records in WIJNEGEM Antwerpen, BE. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Orfit Industries NV between 1999 and 2020. The busiest year on record is 2015, with 2. The most recent is 2020, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K202068 | The AIO Solution 3.0 | IYE | Substantially Equivalent | |
| K200282 | Orfit Aerial Couchtop | LHN | Substantially Equivalent | |
| K191158 | The AIO Solution | IYE | Substantially Equivalent | |
| K171734 | HP PRO Positioning Device | IYE | Substantially Equivalent | |
| K162355 | Raycast MammoRx Carbon Fibre Breast Board | IYE | Substantially Equivalent | |
| K162862 | Raycast High Precision Lung Board Solution | IYE | Substantially Equivalent | |
| K151946 | Thermofit | IYE | Substantially Equivalent | |
| K151207 | Proton Immobilization Solution | IYE | Substantially Equivalent | |
| K141787 | SAGITTILT | IYE | Substantially Equivalent | |
| K131795 | NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS | IYE | Substantially Equivalent | |
| K991319 | RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS | IYE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9613183 | 1000227792 | ORFIT INDUSTRIES NV | 9A, VOSVELD, WIJNEGEM Antwerpen B-2110 BE | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- LGFComponent, Cast
- ISHComponent, External, Limb, Ankle/Foot
- IQIOrthosis, Limb Brace
- IQEOrthosis, Lumbar
- MNEOrthosis, Moldable, Supportive, Skin Protective
- MRIOrthosis, Truncal/Orthosis, Limb
- LRWScissors, General, Surgical
- ILHSplint, Hand, And Components
- EPPSplint, Nasal
- ITCStirrup, External Brace Component
- LWGSurgical Table Cushion
- LHNSystem, Radiation Therapy, Charged-Particle, Medical
- KXJTable, Radiologic
- ITOTwister, Brace Setting
- LHCWarmer, Irrigation Solution
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain