Gertie Marx Epi-Spinal Tray

• • Terminated Z-2868-2016 FDA Class II ·initiated 24 Aug 2016

  Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer.

• • Terminated Z-2684-2016 FDA Class II ·initiated 4 Aug 2016

  Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled Hospira 5% Lidocaine HCL that is a component of some lots of the Spinal Trays.

510(k) Number

K943319 ↗

FDA Product Code

CAZ

Device Class

Class II

Regulation

21 CFR Part 868.5140

Advisory Committee

Anesthesiology

FDA Decision

SESK Substantially Equivalent — Kit

• Spinal Specialties Nerve Block Tray

  Class II

  FDA 510(k) K960100 Active Cleared 24 Apr 1996

• Epidural Anesthesia Tray

  Class II

  FDA 510(k) K935245 Active Cleared 2 May 1994

• Discography Kit

  Class II

  FDA 510(k) K960082 Active Cleared 21 Mar 1996

• Spinal Specialties Pencil-Point Spinal Needle

  Class II

  FDA 510(k) K950820 Active Cleared 30 Jun 1995

• Continuous Epidural Anesthesia Tray

  Class II

  FDA 510(k) K944029 Active Cleared 30 Jun 1995

• Spinal Anesthesia Tray

  Class II

  FDA 510(k) K941343 Active Cleared 11 Aug 1994

See all devices from Spinal Specialties, Inc. →