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K Number
K040650
Device Name
BONAMATES SERIES
Manufacturer
BIOTECH ONE, INC.
Date Cleared
2004-06-03

(84 days)

Product Code
JEY
Regulation Number
872.4760
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The BONAMATES® series are indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton in adults and children.

Device Description

BONAMATES® Series

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the BONAMATES® Series, which are bone plates. It confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.

The document includes:

  • The device name: BONAMATES® Series.
  • The regulation number and name: 872.4760, Bone Plate.
  • The product code: JEY.
  • Indications for Use: Trauma and reconstructive procedures in the midface and craniofacial skeleton in adults and children.

However, it does not include:

  • A table of acceptance criteria or reported device performance.
  • Details about a study (sample size, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance).
  • Information on how ground truth was established for training or testing sets.

Therefore, I cannot provide the requested information based on the input given.

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.