510(k) K010246 ยท HRX Arthroscope
KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A
| Applicant | Kyphon, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 14, 2001 |
| Received | Jan 26, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010246
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2020 | Medtronic Sofamor Danek USA Inc Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the neces Terminated |
HRX | None listed |
| Apr 24, 2020 | Medtronic Sofamor Danek USA Inc Medtronic Bone Void Filler, Small - Product Usage:
is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessar Terminated |
HRX | None listed |
| Apr 24, 2020 | Medtronic Sofamor Danek USA Inc Medtronic Bone Void Filler, Large - Product Usage:
is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessar Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.