Company ยท US
Kyphon, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2008. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 21, 2008 | K073516 | DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR Kyphon, Inc. | BSP |
| Apr 13, 2007 | K063071 | DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B Kyphon, Inc. | BSP |
| Jun 27, 2006 | K061210 | FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B Kyphon, Inc. | BSP |
| Jul 9, 2004 | K041454 | KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A Kyphon, Inc. | HRX |
| Jul 7, 2004 | K041584 | KYPHX HV-R BONE CEMENT, MODEL C01A Kyphon, Inc. | NDN |
| Apr 1, 2004 | K033801 | KYPHX HV-R, MODEL C01A Kyphon, Inc. | NDN |
| Sep 15, 2003 | K032212 | KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A Kyphon, Inc. | HRX |
| Feb 14, 2001 | K010246 | KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A Kyphon, Inc. | HRX |
| Jul 2, 1998 | K981251 | KYPHON INFLATABLE BONE TAMP Kyphon, Inc. | HRX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2008 | Kyphon Inc X-STOP Interspinous Process Decompression (lPD) System,
(With Physician's Guide, P/N 16000789-01 (Ti device), P/N 16001013-01 (PEEK device);
Catalog numbers for X-STOP Titanium Implant: 1-2206 US 6MM Terminated |
NQO | None listed |
| Sep 18, 2008 | Kyphon Inc KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3 Xpander), catalog number KPT1502, manufactured by Medtronic Spine LLC. Device i Terminated |
LXH | None listed |
| Feb 5, 2008 | Kyphon Inc Kyphon, Functional Anaesthetic Discography (F.A.D.) Introducer Needle, Catalog Number: D01B, Kyphon, Inc., Sunnyvale, Ca 94089 Terminated |
BSP | None listed |
| Feb 5, 2008 | Kyphon Inc Functional Anaesthetic Discography (F.A.D.) Catheter
System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089 Terminated |
BSP | K043500 |
| Jul 20, 2004 | Kyphon Inc KyphXR brand KyphoPak Tray, a Introducer Tool kit for Inflation Syringe
Kyphon Catalog Number: KPT1001, KPT1002, KPT1003, KPT1501, KPT1503,
KPT2002, KPT2003
The medical device is distributed by Kyph Terminated |
DXT | None listed |
| Jul 20, 2004 | Kyphon Inc KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A.
Kyphon Catalog Number: A08A. The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation S Terminated |
DXT | K011811 |