Surgical Dynamics Spinal Retractor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K002008 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Modified Auto Suture Endoscopic Gia Surg. Stapler*

  Class II

  FDA 510(k) K900129 Active Cleared 27 Feb 1990

• Auto Suture(R) Endoscopic Gia(Tm) Surgical Stapler

  Class II

  FDA 510(k) K892233 Active Cleared 28 Apr 1989

• Caprosyn Absorbable Suture

  Class II

  FDA 510(k) K032586 Active Cleared 17 Nov 2003

• Auto Suture Disposable Gia Surg. Stapler

  Class I

  FDA 510(k) K801590 Active Cleared 4 Aug 1980

• Endoscope Suture & Carrier

  Class II

  FDA 510(k) K912973 Active Cleared 27 Sep 1991

• Modified Surgiport Disposable Trocar and Sleeve

  Class I

  FDA 510(k) K903419 Active Cleared 9 Aug 1990

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• What is the Surgical Dynamics Spinal Retractor used for?

  The Surgical Dynamics Spinal Retractor is a surgical instrument designed to hold back tissues and expose the operative field during spinal procedures, facilitating visualization and access in orthopedic spinal surgery.

• Is the Surgical Dynamics Spinal Retractor sterile or single-use?

  The device is supplied as a non-sterile, reusable instrument, meaning it is not provided sterile and is intended for multiple uses after appropriate cleaning and sterilization by the healthcare facility.

• What regulatory clearance does the Surgical Dynamics Spinal Retractor have?

  The Surgical Dynamics Spinal Retractor received FDA 510(k) clearance under submission number K002008 on August 16, 2000, and was determined to be substantially equivalent to a predicate device through a traditional clearance pathway.

• What product code and advisory committee classification apply to this device?

  The device is classified under product code HRX and was reviewed by the Orthopedic (OR) advisory committee, reflecting its intended use in orthopedic spinal procedures.