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FDA 510(k)

IN-FAST BONE SCREW SYSTEM

K-Number: K011910 · 2001-07-13

ApplicantAmerican Medical Systems, Inc.
Decision Date2001-07-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IN-FAST BONE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-07-13 under 510(k) number K011910. 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 IN-FAST BONE SCREW SYSTEM?

IN-FAST BONE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2001-07-13. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K011910.

When did IN-FAST BONE SCREW SYSTEM receive FDA 510(k) clearance?

IN-FAST BONE SCREW SYSTEM received FDA 510(k) clearance on 2001-07-13, under 510(k) number K011910.

Who is the listed applicant for IN-FAST BONE SCREW SYSTEM?

The FDA 510(k) record lists American Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IN-FAST BONE SCREW SYSTEM?

The FDA product code for IN-FAST BONE SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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Official Source

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

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