SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE by SYNTEC SCIENTIFIC CORP.

The titanium alloy Mini plate is provided non-sterile. The device is intended to treat fractures of various bones, including the clavicle, scapula, pelvis, calcaneus, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and plialanges).

Device Description

The Mini plate is device, which is fastened to bone for purpose of providing fixation. The device is principally differentiated by its function. Thus there is various types and sizes of bone fixation plates. The Mini plate is geometry shape as follows: Straight, L-shaped, T-shaped, H-shaped, Condylar, Cloverleaf, Calcaneal, and Straight Reconstruction. The plate must be used for various sizes of screw onto bone fixation. The device range in thickness from 0.9 to 2.8 mm, width from 3.8 to 15.2 mm, length from 17 to 262 mm, and hole number from 3 to 22 holes.

AI/ML Overview

I am sorry, but the provided text only contains regulatory information and a description of the device (Syntec-Taichung Non-sterile Titanium Alloy Mini Plate). It does not include any information regarding acceptance criteria, study details, performance data, or ground truth establishment for the device.

Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets the acceptance criteria. The document is primarily a 510(k) clearance letter from the FDA, confirming substantial equivalence to a predicate device.

Summary

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510(k) Summary of Safety and effectiveness

Sponsor: Syntec-Taichung Medical Instruments Co., Ltd. 2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua, Taiwan. 509 Phone / FAX: 886-4-7987099 / 886-4-7987077 Contact Person: Ted Y. Shi
A Proprietary Name : Syntec-Taichung Non-sterile Titanium Alloy Mini Plate
Common Name : Various Types and Sizes of Bone Fixation Plate
Classification Status : Class II, CFR 888.3030
A Device Product Code : 87 RHS
Material: This device is manufactured from commercially Ti-6Al-4V.
A Indication for Use :

A Description of the Device :

Plate Name	Geometry Shapes
Mini	Straight, L-shaped, T-shaped, H-shaped, Condylar, Cloverleaf,Calcaneal, and Straight Reconstruction

The plate must be used for various sizes of screw onto bone fixation. The device range in thickness from 0.9 to 2.8 mm, width from 3.8 to 15.2 mm, length from 17 to 262 mm, and hole number from 3 to 22 holes.

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Image /page/1/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 1999

Mr. Ted Y. Shi President Syntec-Taichung Medical Instruments Company Limited 2, Kung San Road, Chaun Shing Industrial Zone, Shen Kang Chang Hua, Taiwan 509

Re : K983988 Syntec-Taichung Non-sterile Titanium Alloy Mini Plate Regulatory Class: II Product Code: HRS Dated: November 4, 1998 Received: November 9, 1998

Dear Mr. Shi:

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 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 The general controls provisions of the Act of the Act. include reguirements 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 Regulations, Title 21, Parts 800 to 895. ਸਿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug 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. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 r through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Ted Y. Shi

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21 CFR 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.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.

a M. Witten, Ph.D., M.D. Celi Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

1398 510(K) Number (if known): _ Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

ે છે.
વર્ષના સાથે સાચના પાસની તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા

Over-The-Counter-Use_

(Optional Format 1-2-96)

887 9839

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.