Oped Canada Distribution · 89-08 · CANADA
For Oped Canada Distribution, import alert is 89-08; country is CANADA; 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 Matrix II; Bone Growth Stimulator | Matrix II; Bone Growth Stimulator; product code is 87 L - - OE Stimulator, invasive bone growth | 87 L - - OF Stimulator, bone growth, non-invasive; date published is 09/16/2009; address is 344 Townsend Ave , Burlington, ON CANADA, verified against its source on 2026-09-30.
- Firm
- Oped Canada Distribution 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
- CANADA verified
- Address
- 344 Townsend Ave , Burlington, ON CANADA verified
- Date published
- 09/16/2009 verified
- Product code
- 87 L - - OE Stimulator, invasive bone growth | 87 L - - OF Stimulator, bone growth, non-invasive each item verified
- Product
- Matrix II; Bone Growth Stimulator | Matrix II; Bone Growth Stimulator each item verified
- FDA notes
- The manufacturers website and the user manual shipped with the product states the product ; Class III; 10/28/2005 | The manufacturers website and the user manual shipped with the product states the product ; Class III; 10/28/2005 each item verified
What the source says
Oped Canada Distribution Date Published : 09/16/2009 344 Townsend Ave , Burlington, ON CANADA
— 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
87 L - - OE Stimulator, invasive bone growth Date Published: 06/04/2019 Desc: Matrix II; Bone Growth Stimulator Notes: The manufacturers website and the user manual shipped with the product states the product ; Class III; 10/28/2005 87 L - - OF Stimulator, bone growth, non-invasive Date Published: 06/04/2019 Desc: Matrix II; Bone Growth Stimulator Notes: The manufacturers website and the user manual shipped with the product states the product ; Class III; 10/28/2005
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html