(59 days)
Rigid fixation of cranio, facial and neurological bone.
The titanium bone plates and screws are manufactured in various sizes, with various design features for cranio, facial, and neurological surgical procedures.
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Lorenz Sterile Bone Plates and Screws." This document does not describe:
- Acceptance criteria or device performance data. The letter merely states that the device is substantially equivalent to legally marketed predicate devices.
- Any specific study details. There is no mention of clinical trials, performance studies, sample sizes, expert involvement, or ground truth methodologies.
Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval letter, not a technical report detailing product performance or study design.
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Ka72322
Attachment II
Aud 1 8 mill
(
Safety and Effectiveness Information
Device Name: Lorenz Sterile Bone Plates and Screws
Device Classification: Class II
-
Device Description: The titanium bone plates and screws are manufactured in various sizes, with various design features for cranio, facial, and neurological surgical procedures.
Drawing Samples are displayed in Attachment I. -
Potential Risks: A sterilization validation along with a package validation gives a high level of assurance for the sterility of the device.
A sample of the package insert is displayed in Attachment I to address other potential risks .
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1997
Ms. Diana Preston Requlatory Specialist Walter Lorenz Surgical, Incorporated 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K972322 Lorenz 1.5mm Neuro Pack/Lorenz 2.0 FT Trade Name: Plates (sterile version) Regulatory Class: II Product Code: JEY Dated: June 17, 1997 June 20, 1997 Received:
Dear Ms. Preston:
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 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. ರ್ಗ 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 requlation (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
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Page 2 - Ms. Preston
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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 ene regaración cherciou) Messfallers 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,
Octaviest
hy A. Ulatowski Dired tor 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) Number (if known): unknown
Device Name: Lorenz Sterile Bone Plates and Bone Screws
Indications For Use: Rigid fixation of cranio, facial and neurological bone.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off) Division of Dental, Int and General Heapts 510(k) Number
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
:
(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.