Kyphon, Inc.

Medical device manufacturer in Sunnyvale, CA.

9510(k) clearances
0PMA approvals
4recalls

Device types

510(k) clearances

510(k)DeviceDecision
K073516Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct…BSP · Traditional 02/21/2008SE
K063071Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BBSP · Special 04/13/2007SE
K061210Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…BSP · Special 06/27/2006SE
K041454Kyphx Xpander Inflatable Bone Tamps MODEL#KO8A,KO9A,K13AHRX · Traditional 07/09/2004SE
K041584Kyphx Hv-R Bone Cement, Model C01ANDN · Traditional 07/07/2004SE
K033801Kyphx Hv-R, Model C01ANDN · Traditional 04/01/2004SE
K032212Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AHRX · Traditional 09/15/2003SE
K010246Kyphx Inflatable Bone Tamp, Size 20/3,MODEL K01A, Kyphx Inflatable Bone Tamp, Size 15/3…HRX · Traditional 02/14/2001SE
K981251Kyphon Inflatable Bone TampHRX · Traditional 07/02/1998SE

Recalls

RecallProductInitiated
Z-2347-2008 KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the…Some products may contain the incorrect introducer stylet. If the treating physician is unfamiliar with the… 06/23/2008Terminated
Z-1765-2008 X-STOP Interspinous Process Decompression (lPD) System, (With Physician's Guide, P/N…Physician instructions revised due to product breakage: During the implantation of the X-STOP IPD Device… 01/30/2008Terminated
Z-0949-2008 Kyphon, Functional Anaesthetic Discography (F.A.D.) Introducer Needle, Catalog Number:…Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure. 04/25/2006Terminated
Z-0948-2008 Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon…Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure. 04/25/2006Terminated