THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010

• K Number: K983535
• Device Name: THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010
• Manufacturer: HANS HERMANN GMBH
• Date Cleared: 1998-12-29 ( 81 days)
• Product Code: JEY
• Regulation Number: 872.4760
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

The Hermann Titanium (Mini/Micro/Medium) plating systems are intended for maxillo-facial surgery.

The various sizes are designed to accommodate osteosynthesis requirements in pediatric and adult patients.

Medical Indications

Fractures in maxillo-facial bones -

Device Description

The Titanium Miniplating System H12-10104 - H19-30302
The Titanium Microplating System H22-01990 - H29-30302
The Titanium Mediumplating System H32-06104 - H39-30302

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for a "Titanium Miniplating System," indicating its substantial equivalence to a predicate device.

The letter does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study, sample sizes for test or training sets, data provenance, ground truth establishment, or expert involvement.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the given input.

Regulation Number and Section

§ 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.