Pwb Lumbosacral Spine System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K920116 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SN

• Synergy 6.35mm Ss Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System

  Class II

  FDA 510(k) K973836 Active Cleared 5 Mar 1998

• Cross Medical - Synergy(Tm) Spine System

  Class II

  FDA 510(k) K940631 Active Cleared 13 Jul 1995

• Cross Medical Product Pedicle Awl

  Class I

  FDA 510(k) K895587 Active Cleared 4 Jan 1990

• Synergy Ti Anterior Spinal System

  Class II

  FDA 510(k) K950709 Active Cleared 25 Oct 1995

• Pwb Lumbar Laminar Hooks with Set Screws

  Class II

  FDA 510(k) K924381 Active Cleared 18 May 1993

• Synergy Closed Variable Locking Screw (Vls), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems

  Class II

  FDA 510(k) K974749 Active Cleared 13 Mar 1998