510(k) K041454 ยท HRX Arthroscope
KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
| Applicant | Kyphon, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 9, 2004 |
| Received | Jun 1, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041454
| 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 |
| Sep 9, 2011 | Medtronic Spine LLC (formerly Kyphon Inc.) Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC (formerly known as K Terminated |
HRX | None listed |
| May 11, 2009 | Medtronic Spine LLC, formerly Kyphon Inc KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery. Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.