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K120599 (Page 1 of 2)Section 5: 510 (k) Summary (As required by 21 CER 807.92 and 21 CER 807.93)APAR302130211Submitter Information NameDePuy Orthopedics, Inc. Address700 Orthopedic Drive, Warsaw,

How to fill out section 5 510 k

How to fill out section 5 510 k

1. To fill out section 5 of the 510(k) form, follow these steps:
2. Start by carefully reading the instructions provided for section 5.
3. Provide the necessary information in the designated fields.
4. Begin by entering the submission type, which should be 'Traditional' or 'Abbreviated'.
5. Fill in the required details about the device, including product code, device name, and classification.
6. Provide information about the predicate device(s) and their substantial equivalence to the device being submitted.
7. If applicable, include information about any changes or modifications to the device.
8. Ensure that all the information provided is accurate and complete.
9. Review the filled-out section 5 for any errors or missing information before submitting the form.
10. Once reviewed, move on to the next section of the 510(k) form.
11. Seek guidance from the FDA or consult the official instructions if you encounter any difficulties.

Who needs section 5 510 k?

1. Section 5 of the 510(k) form must be filled out by medical device manufacturers or entities seeking clearance from the FDA for their medical devices. Anyone intending to market a new medical device, modify an existing device, or demonstrate substantial equivalence to a predicate device should provide the necessary information in section 5.

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What is section 5 510 k?

Section 5 510 k refers to the premarket notification submission for medical devices.

Who is required to file section 5 510 k?

Any person who intends to market a medical device in the United States is required to file section 5 510 k with the FDA.

How to fill out section 5 510 k?

Section 5 510 k should be filled out with detailed information about the medical device, including its intended use, technological characteristics, and performance data.

What is the purpose of section 5 510 k?

The purpose of section 5 510 k is to demonstrate that a medical device is substantially equivalent to a predicate device already on the market, and therefore can be marketed without further regulatory review.

What information must be reported on section 5 510 k?

Section 5 510 k must include information on the device's indications for use, scientific justifications for its safety and efficacy, and any potential adverse effects.