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FDA 510(k)

LACTOSCREW SCREW ANCHOR

K-Number: K033355 · 2004-06-30

ApplicantBiomet Orthopedics, Inc.
Decision Date2004-06-30
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LACTOSCREW SCREW ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2004-06-30 under 510(k) number K033355. 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 LACTOSCREW SCREW ANCHOR?

LACTOSCREW SCREW ANCHOR is a medical device that received FDA 510(k) clearance on 2004-06-30. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K033355.

When did LACTOSCREW SCREW ANCHOR receive FDA 510(k) clearance?

LACTOSCREW SCREW ANCHOR received FDA 510(k) clearance on 2004-06-30, under 510(k) number K033355.

Who is the listed applicant for LACTOSCREW SCREW ANCHOR?

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

What is the FDA product code for LACTOSCREW SCREW ANCHOR?

The FDA product code for LACTOSCREW SCREW ANCHOR is HWC. This falls under the Cardiovascular category.

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Other records listing Biomet Orthopedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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