(15 days)
The Stryker® MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth.
The document is a 510(k) summary for a medical device (Stryker® MMF Screw) establishing substantial equivalence to a predicate device. It defines the intended use and regulatory classification but does not include any performance study details or acceptance criteria.
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MAR 17 2005
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Stryker® MMF Screw
General Information
| Proprietary Name: | Stryker® MMF Screw |
|---|---|
| Common Name: | Small Bone Screws |
| Proposed Regulatory Class: | Class II |
| Device Classification: | 76 DZL21 CFR 872.4880, Intraosseous FixationScrew or Wire |
| Submitter: | Stryker®InstrumentsLeibinger Micro Implants4100 East Milham AvenueKalamazoo, MI 49001877-534-2464 x 4062 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Nathan M. MiersmaRegulatory Affairs RepresentativePhone: 877-534-2464 x 4062Fax: 269-323-4215 |
Intended Use
The Stryker® MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.
Substantial Equivalence
EQUIVALENT PRODUCTS:
The Stryker® MMF Screw is substantially equivalent to the Leibinger® IMF Screw, K963030 (Howmedica Leibinger).
Rothschild
Nathan M. Miersma Regulatory Affairs Representative Stryker® Instruments Leibinger Micro Implants Division
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
MAR 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker® Instruments Mr. Nathan M. Miersma Regulatory Affairs Representative Stryker Instruments, Leibinger Division 4100 East Avenue Kalamazoo, Michigan 49001
Rc: K050535
Trade/Device Name: Stryker® MMF Screw Regulation Number: 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: March 1, 2005 Received: March 2, 2005
Dear Mr. Miersma:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reveal above and have determined the device is substantially equivalent (for the referenced above and have and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device micisate conmisive prior to read have been reclassified in accordance with the provisions of Amendinens, or to do roos and have a ct (Act) that do not require approval of a premarket the I cucur I vou, Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, listing of devices, good manufacturing practice, requirements prohibitions against misbranding and adulteration.
If your device is classified (sec above) into either class II (Special Controls) or class III If your device is classified (See h additional controls. Existing major regulations affecting (1 Mrx), it may of subject to the of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Miersma
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualles of a substantines with other requirements
mean that FDA has made a determination that your device the Federal occepcios mean that FDA has made a decemination and regulations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by seciences and of the Act of ally rederal statues and reguirements, including, but not limited to: registration protice You must colliply with an the Act 5 read 801); good manufacturing practice.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); grood manufacturing practice and if the (21 CFR i art 607), labeling (21 CFR (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality byections (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneraling of substantial equivalence of your device to a premarket notification. THE FDT matts 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), If you desire specific advice to: your as at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Punnes
S. Chia-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosurc
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Indications for Use
510(k) Number (if known):
Device Name: Stryker® MMF Screw
Indications For Use:
The Stryker® MMF Screw is intended for use as a bone screw in temporary maxillomandibular fixation, providing indirect stabilization of fractures of the maxilla, mandible or both, where is sufficient occlusion.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ramsey
(RN)
Microbiology, General Hospital
Infection Control, Dental Devices
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§ 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.