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FDA 510(k)

BIOMET BONE SCREW

K-Number: K964970 · 1997-04-03

ApplicantBiomet, Inc.
Decision Date1997-04-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOMET BONE 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 1997-04-03 under 510(k) number K964970. 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 BIOMET BONE SCREW?

BIOMET BONE SCREW is a medical device that received FDA 510(k) clearance on 1997-04-03. The listed applicant is Biomet, Inc.. The 510(k) number is K964970.

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

BIOMET BONE SCREW received FDA 510(k) clearance on 1997-04-03, under 510(k) number K964970.

Who is the listed applicant for BIOMET BONE 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 BIOMET BONE SCREW?

The FDA product code for BIOMET BONE 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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