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K Number
K011856
Device Name
RADIOGRAPHIC MARKERS
Manufacturer
ENCORE ORTHOPEDICS, INC.
Date Cleared
2001-08-22

(70 days)

Product Code
NEU,FZP
Regulation Number
878.4300
Type
Traditional
Panel
SU
Reference & Predicate Devices
K010348
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Radiographic Markers are intended for implantation in the bone to aid the surgeon in radiographic assessment of total hip or knee component movement.

Device Description

The Radiographic Markers are spherical in shape and available in 00.8-1.0 mm. The Radiographio hauters antalum conforming to the composition called out in ASTM F560-98.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Radiographic Markers) and does not contain a study demonstrating the device meets acceptance criteria. The document states that the device is substantially equivalent to a predicate device based on comparable materials, design, and indications for use. Therefore, I cannot provide the requested information.

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.