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K Number
K970036

Validate with FDA (Live)

Device Name
FIXATION PIN OR ROD
Manufacturer
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
Date Cleared
1997-03-25

(81 days)

Product Code
HTY
Regulation Number
888.3040
Type
Traditional
Panel
Orthopedic
Age Range
All
Reference & Predicate Devices
K953194
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Both the Surgical Dynamics™ Bone Pin** and the Poly-Medics Lactosorb® Bone Pin (K953194) are intended for fixation of small bone fragments in non-load bones with appropriate immobilization.

Device Description

The Surgical Dynamics™ Bone Pin** is a resorbable fixation pin intended for fixation of small bone fragments in non-load bones with appropriate immobilization. It will be available in a range of sizes and will be supplied without attached K-wires.

AI/ML Overview

I apologize, but the provided text describes a medical device (Surgical Dynamics™ Bone Pin) and its intended use, materials, and predicate device. It is a 510(k) premarket notification summary from 1997.

This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the other specific details requested in your prompt (e.g., MRMC studies, standalone performance, training set details).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input, as the necessary information is completely absent.

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United States Surgical Corporation 510(k) Premarket Notification Surgical Dynamics™ Bone Pin** MAR 2 5 1997 K9 +0036 510(k) SUMMARY OF INFORMATION: United States Surgical Corporation SUBMITTER: 150 Glover Avenue Norwalk, CT 06856 (203) 845-1000 CONTACT PERSON: Melissa Mazzoni December 31, 1996 DATE PREPARED: CLASSIFICATION NAME: Pin, Fixation, Smooth or threaded metallic bone fixation fastener COMMON NAME: Fixation Pin or Rod Trademark name not yet determined. PROPRIETARY NAME: The Surgical Dynamics™ Bone Pin** is a resorbable DEVICE DESCRIPTION: fixation pin intended for fixation of small bone fragments in non-load bones with appropriate immobilization. It will be available in a range of sizes and will be supplied without attached K-wires. Poly-Medics Lactosorb® Bone Pin (K953194) PREDICATE DEVICE: Both the Surgical Dynamics™ Bone Pin** and the Poly-INTENDED USE: Medics Lactosorb® Bone Pin (K953194) are intended for fixation of small bone fragments in non-load bones with appropriate immobilization. Both the Surgical Dynamics™ Bone Pin** and the Poly-MATERIALS: Medics Lactosorb® Bone Pin (K953194) are comprised of biosafe materials.

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