(451 days)
Temporary ligature and wire lock fixation for temporary constriction and stabilization of fractured bone segments in the oral cavity in conjunction with primary fixation devices.
Smooth or threaded metallic bone fixation fastener; Intraoral ligature and wire lock. Bone screws and associated instruments (Drill bits, screwdrivers,etc.) in conjunction with ligature wire and associated instruments (wire twisters, cutters, etc.)
This section is not applicable, as it is a 510(k) premarket notification for a medical device (bone fixation fastener, ligature, and wire lock) and does not involve AI/ML device performance studies. The document describes the FDA's clearance of the device for market based on substantial equivalence, rather than detailing a study against acceptance criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bruce R. Horowitz Manager, RA/QA OsteoMed Corporation 3750 Realty Road Dallas, Texas 75244
OCT 10 1997
Re: K962774 Osteomed QUICK-FLIX™ Trade Name: Requlatory Class: II Product Code: DZL July 9, 1997 Dated: Received: July 10, 1997
Dear Mr. Horowitz:
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, Druq, 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 requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 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. Horowitz
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" (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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Osteomed "Indications for Use" Submission
510(K) Number: K962774
Osteomed QuickFix™ Device name: Smooth or threaded metallic bone fixation fastener; Intraoral ligature and wire lock. Bone screws and associated instruments (Drill bits, screwdrivers,etc.) in conjunction with ligature wire and associated instruments (wire twisters, cutters, etc.) Indications For Use: Temporary ligature and wire lock fixation for temporary constriction and stabilization of fractured bone segments in the oral cavity in conjunction with primary fixation devices.
Prescription Use . (Per 21 CFR 801.109)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number _
§ 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.