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FDA 510(k)

TIMESH SELF DRILLING SCREW

K-Number: K062348 · 2006-09-08

ApplicantMedtronic Neurosurgery
Decision Date2006-09-08
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TIMESH SELF DRILLING SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurosurgery. It received FDA 510(k) clearance on 2006-09-08 under 510(k) number K062348. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIMESH SELF DRILLING SCREW?

TIMESH SELF DRILLING SCREW is a medical device that received FDA 510(k) clearance on 2006-09-08. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K062348.

When did TIMESH SELF DRILLING SCREW receive FDA 510(k) clearance?

TIMESH SELF DRILLING SCREW received FDA 510(k) clearance on 2006-09-08, under 510(k) number K062348.

Who is the listed applicant for TIMESH SELF DRILLING SCREW?

The FDA 510(k) record lists Medtronic Neurosurgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TIMESH SELF DRILLING SCREW?

The FDA product code for TIMESH SELF DRILLING SCREW is HWC. This falls under the Cardiovascular category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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