510(k) K122378 ยท KWP Appliance, Fixation, Spinal Interlaminal
NEXTGEN ALTIUS OCT SYSTEM
| Applicant | Biomet Spine (Aka Ebi, LLC), Parsippany NJ, US |
| Decision | Substantially Equivalent, Sep 20, 2012 |
| Received | Aug 6, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122378
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2015 | Biomet Spine, LLC Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch.
The Lineum syste Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.