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FDA 510(k)

BONE MULCH SCREW

K-Number: K941941 · 1995-02-02

ApplicantBiomet, Inc.
Decision Date1995-02-02
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BONE MULCH SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1995-02-02 under 510(k) number K941941. 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 for Some Indications.

Frequently Asked Questions

What is the BONE MULCH SCREW?

BONE MULCH SCREW is a medical device that received FDA 510(k) clearance on 1995-02-02. The listed applicant is Biomet, Inc.. The 510(k) number is K941941.

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

BONE MULCH SCREW received FDA 510(k) clearance on 1995-02-02, under 510(k) number K941941.

Who is the listed applicant for BONE MULCH SCREW?

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 BONE MULCH SCREW?

The FDA product code for BONE MULCH SCREW 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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