QUICK TAP SELF DRILLING SCREW by KINAMED, INC.

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

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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.

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Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 SEP

Mr. Robert Bruce Vice President, Sales & Marketing Kinamed, Incorporated 2192-C Anchor Court Newbury Park, California 91320

Re : K982927 Trade Name: Quick Tap Self Drilling Screw Regulatory Class: II Product Code: DZL Dated: August 19, 1998 Received: August 20, 1998

Dear Mr. Bruce:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Bruce

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97) . Other general *** information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

S. Dutman for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 1-3

Kinamed NeuroPro™ , Quick Tap™ Self Drilling Screws

Modification To 510(k) No. K964362

Statement Of Indications For Use

KGXADD 510(k) Number (if known):

Device Name: Kinamed NeuroPro™ , Quick Tap™ Self Drilling Screws

Indications For Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russer

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_100 x) 100

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use_

Regulation Number and Section

§ 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.