Ortomed B V · 89-08 · NETHERLANDS
For Ortomed B V, import alert is 89-08; country is NETHERLANDS; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Implantable Device | Implantable Device | Implantable Device; product code is 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 87 - - - -- Orthopedic; date published is 06/20/2019; address is Fruiteniersstraat 23 , Postbus 1081 , Zwijndrecht, Zuid-Holland NETHERLANDS, verified against its source on 2026-09-30.
- Firm
- Ortomed B V verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- NETHERLANDS verified
- Address
- Fruiteniersstraat 23 , Postbus 1081 , Zwijndrecht, Zuid-Holland NETHERLANDS verified
- Date published
- 06/20/2019 verified
- Product code
- 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 87 - - - -- Orthopedic each item verified
- Product
- Implantable Device | Implantable Device | Implantable Device each item verified
- FDA notes
- DWPE Date; 4/23/1992 | DWPE Date; 4/23/1992 | DWPE Date; 4/23/1992 each item verified
What the source says
Ortomed B V Date Published : 06/20/2019 Fruiteniersstraat 23 , Postbus 1081 , Zwijndrecht, Zuid-Holland NETHERLANDS
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
76 - - - -- Dental Date Published: 06/20/2019 Desc: Implantable Device Notes: DWPE Date; 4/23/1992 77 - - - -- Ear,Nose And Throat Date Published: 06/20/2019 Desc: Implantable Device Notes: DWPE Date; 4/23/1992 87 - - - -- Orthopedic Date Published: 06/20/2019 Desc: Implantable Device Notes: DWPE Date; 4/23/1992
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html