Kyphx Hv-R, Model C01A

• 2 recalls, same reason

  • Terminated Z-1624-2011 FDA Unclassified (pre-2012) ·initiated 10 Nov 2009
  • Terminated Z-1625-2011 FDA Unclassified (pre-2012) ·initiated 10 Nov 2009 ·via K033801, on the same 510(k)

  Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K033801 ↗

FDA Product Code

NDN

Device Class

Class II

Regulation

21 CFR Part 888.3027

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B

  Class II

  FDA 510(k) K063071 Active Cleared 13 Apr 2007

• Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, Regular

  Class II

  FDA 510(k) K073516 Active Cleared 21 Feb 2008

• Kyphx Hv-R Bone Cement Model C01A

  Class II

  FDA 510(k) K041584 Active Cleared 7 Jul 2004

• Kyphon Inflatable Bone Tamp

  Class II

  FDA 510(k) K981251 Active Cleared 2 Jul 1998

• Kyphx Inflatable Bone Tamp, Size 20/3, Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02A

  Class II

  FDA 510(k) K010246 Active Cleared 14 Feb 2001

• Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer Needle, Model D01B

  Class II

  FDA 510(k) K061210 Active Cleared 27 Jun 2006

See all devices from Kyphon, Inc. →