(81 days)
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 -
The Titanium Miniplating System H12-10104 - H19-30302
The Titanium Microplating System H22-01990 - H29-30302
The Titanium Mediumplating System H32-06104 - H39-30302
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.
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Image /page/0/Picture/2 description: The image shows a partial view of a circular emblem or logo. The text "DEPARTMENT OF HEALTH & HUMAN" is visible along the curved edge of the circle. Inside the circle, there are three stylized, parallel lines that appear to be part of a larger design, possibly representing a symbol or abstract graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 29 1998
Hans Hermann GmbH C/O Mr. Dagmar S. Maser FDA Reqularoty Liaison Business Support International Amstel 320-I Amsterdam, The Netherlands
Re: K983535 The Titanium Miniplating System, The Trade Name: Titanium Microplating Requlatory Class: II Product Code: JEY October 2, 1998 Dated: Received: October 9, 1998
Dear Mr. Maser:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 Reqister. Please note: 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. Maser
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 requlation 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.gov/cdrh/dsma/dsmama1n.html" .
Sincerely yours,
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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510(k) - 76 JEY
Hans Hermann GmbH
510(k) Number
DEVICE Names
983535
The Titanium Miniplating System H12-10104 - H19-30302 The Titanium Microplating System H22-01990 - H29-30302 The Titanium Mediumplating System H32-06104 - H39-30302
INDICATIONS FOR 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 -
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K983535 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per CFR 801 109) | |
|---|---|
| --------------------------------------- | -- |
OR
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |
HER-Ind.JEY
(Optional Format 1-2-96)
§ 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.