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K Number
K982927
Device Name
QUICK TAP SELF DRILLING SCREW
Manufacturer
KINAMED, INC.
Date Cleared
1998-09-08

(19 days)

Product Code
DZL
Regulation Number
872.4880
Type
Special
Panel
DE
Reference & Predicate Devices
K964362
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Kinamed NeuroPro™ , Quick Tap™ Self Drilling Screws are indicated for use in conjunction with bone plates and mesh implants of the parent NeuroPro System in internal fixation of fractures and osteotomies of the craniofacial skeleton including fixation of cranial bone flap osteotomies as well as for reconstruction of bony defects and deficits of the craniofacial skeleton.

The Kinamed NeuroPro™ , Quick Tap™ Self Drilling Screws are not indicated for use in the spine.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA, along with the indications for use for the Kinamed NeuroPro™, Quick Tap™ Self Drilling Screws. This document does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the given input.

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.