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FDA 510(k)

LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE

K-Number: K032072 · 2003-10-01

ApplicantArthrotek, Inc.
Decision Date2003-10-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Arthrotek, Inc.. It received FDA 510(k) clearance on 2003-10-01 under 510(k) number K032072. 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 LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE?

LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE is a medical device that received FDA 510(k) clearance on 2003-10-01. The listed applicant is Arthrotek, Inc.. The 510(k) number is K032072.

When did LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE receive FDA 510(k) clearance?

LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE received FDA 510(k) clearance on 2003-10-01, under 510(k) number K032072.

Who is the listed applicant for LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE?

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

What is the FDA product code for LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE?

The FDA product code for LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE 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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