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FDA 510(k)

LACTOSORB MINI INTERFERENCE SCREW

K-Number: K021254 · 2002-07-17

ApplicantBiomet Orthopedics, Inc.
Decision Date2002-07-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LACTOSORB MINI INTERFERENCE SCREW 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 2002-07-17 under 510(k) number K021254. 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 MINI INTERFERENCE SCREW?

LACTOSORB MINI INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 2002-07-17. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K021254.

When did LACTOSORB MINI INTERFERENCE SCREW receive FDA 510(k) clearance?

LACTOSORB MINI INTERFERENCE SCREW received FDA 510(k) clearance on 2002-07-17, under 510(k) number K021254.

Who is the listed applicant for LACTOSORB MINI INTERFERENCE SCREW?

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 LACTOSORB MINI INTERFERENCE SCREW?

The FDA product code for LACTOSORB MINI INTERFERENCE SCREW 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

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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