DRG ORTHOHEX SS BONE SCREW

• K Number: K013786
• Device Name: DRG ORTHOHEX SS BONE SCREW
• Manufacturer: DOCTOR'S RESEARCH GROUP, INC.
• Date Cleared: 2001-12-17 ( 33 days)
• Product Code: HWC
• Regulation Number: 888.3040
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: N/A

Intended Use

The DRG OrthoHex SS bone screws are intended for orthopedic trauma and reconstruction.

Device Description

DRG OrthoHex SS Bone Screw

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a medical device (DRG Orthohex SS Bone Screw). It does not contain any information regarding acceptance criteria, device performance studies, or AI/software validation.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on clinical performance or AI-related evaluations.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.