510(k) K033801 ยท NDN Cement, Bone, Vertebroplasty
KYPHX HV-R, MODEL C01A
| Applicant | Kyphon, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 1, 2004 |
| Received | Dec 8, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033801
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2011 | Medtronic Spine LLC, formerly Kyphon Inc Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Numbe Terminated |
NDN | None listed |
| Mar 11, 2011 | Medtronic Spine LLC, formerly Kyphon Inc Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to tw Terminated |
JDZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.