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FDA 510(k)

MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM

K-Number: K020446 · 2002-03-13

ApplicantAmerican Medical Systems, Inc.
Decision Date2002-03-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION 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 2002-03-13 under 510(k) number K020446. 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 MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM?

MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2002-03-13. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K020446.

When did MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM received FDA 510(k) clearance on 2002-03-13, under 510(k) number K020446.

Who is the listed applicant for MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION 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 MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM?

The FDA product code for MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM is HWC. This falls under the Cardiovascular category.

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Related Devices (Code: HWC)

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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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