Medical Device Manufacturer · US , Sunnyvale , CA

Kyphon, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1998

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Kyphon, Inc. Orthopedic ✕

6 devices

1-6 of 6

Cleared Jul 09, 2004

KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A

Orthopedic · 38d

Cleared Jul 07, 2004

KYPHX HV-R BONE CEMENT, MODEL C01A

Orthopedic · 23d

Cleared Apr 01, 2004

KYPHX HV-R, MODEL C01A

Orthopedic · 115d

Cleared Sep 15, 2003

KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A

Orthopedic · 56d

Cleared Feb 14, 2001

KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP,...

Orthopedic · 19d

Cleared Jul 02, 1998

KYPHON INFLATABLE BONE TAMP

Orthopedic · 87d