FDA 510(k) Applications Submitted by KYPHON, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K061210 |
05/01/2006 |
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B |
KYPHON, INC. |
| K041584 |
06/14/2004 |
KYPHX HV-R BONE CEMENT, MODEL C01A |
KYPHON, INC. |
| K063071 |
10/06/2006 |
DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B |
KYPHON, INC. |
| K033801 |
12/08/2003 |
KYPHX HV-R, MODEL C01A |
KYPHON, INC. |
| K041454 |
06/01/2004 |
KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A |
KYPHON, INC. |
| K010246 |
01/26/2001 |
KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A |
KYPHON, INC. |
| K981251 |
04/06/1998 |
KYPHON INFLATABLE BONE TAMP |
KYPHON, INC. |
| K073516 |
12/14/2007 |
DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR |
KYPHON, INC. |
| K032212 |
07/21/2003 |
KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A |
KYPHON, INC. |
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