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K Number
K964087
Device Name
BLOCK STOP WIRES
Manufacturer
FERGUSON MEDICAL
Date Cleared
1996-11-25

(45 days)

Product Code
HTY
Regulation Number
888.3040
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
K831005
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Block Stop Wires device is intended for use in the osteosyntheses of epiphysial fractures with small osteoarticular fragments and for temporary support of dislocations of small articulations.

Device Description

The Block Stop Wires device is an internal wire fixation device to be used on various types of articular fractures.

AI/ML Overview

I apologize, but the provided text from the document "K964087" is a 510(k) summary for a medical device called "Block Stop Wires." It describes the classification, substantial equivalence, device description, intended use, and technological characteristics of the device.

However, the document does not contain any information regarding acceptance criteria, device performance study results, sample sizes, expert qualifications, ground truth, or adjudication methods. Therefore, I cannot generate the requested table or answer your specific questions based on the input provided.

To answer your questions, I would need a document that details the device's validation studies and performance evaluation.

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Image /page/0/Picture/0 description: The image shows the logo for Ferguson Medical. The logo consists of a stylized letter "M" on the left, followed by the words "FERGUSON" and "MEDICAL" stacked on top of each other on the right. The font is bold and sans-serif, and the entire logo is in black.

916-342-4133 FAX: 916-343-4541

NOV 25 1996

10 September 1996

K964087

510 ( k ) SUMMARY

The 510(k) summary information required by 21 CFR 807.92 is as follows:

  • A. Classification name: Pin, fixation, smooth.
    Common/usual name: Fixation wire, fixation pin, and others

Proprietary name: Block Stop Wires

  • B. Substantial equivalence: Kirschner Medical Wire and Steinman Pins (K831005), and others.
  • C. Device description: The Block Stop Wires device is an internal wire fixation device to be used on various types of articular fractures.
  • D. Intended use: The Block Stop Wires device is intended for use in the osteosyntheses of epiphysial fractures with small osteoarticular fragments and for temporary support of dislocations of small articulations.
  • E. Technological characteristics: The Block Stop Wires device is similar to predicate devices in its design, function, and intended use.

N/A