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FDA 510(k)

MODIFICATION TO BONE MULCH SCREW SYSTEM

K-Number: K993025 · 1999-10-08

ApplicantBiomet, Inc.
Decision Date1999-10-08
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO BONE MULCH SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1999-10-08 under 510(k) number K993025. 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 BONE MULCH SCREW SYSTEM?

MODIFICATION TO BONE MULCH SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1999-10-08. The listed applicant is Biomet, Inc.. The 510(k) number is K993025.

When did MODIFICATION TO BONE MULCH SCREW SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO BONE MULCH SCREW SYSTEM received FDA 510(k) clearance on 1999-10-08, under 510(k) number K993025.

Who is the listed applicant for MODIFICATION TO BONE MULCH SCREW SYSTEM?

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

What is the FDA product code for MODIFICATION TO BONE MULCH SCREW SYSTEM?

The FDA product code for MODIFICATION TO BONE MULCH SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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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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