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FDA 510(k)

TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES

K-Number: K982953 · 1998-10-21

ApplicantBiomet, Inc.
Decision Date1998-10-21
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1998-10-21 under 510(k) number K982953. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES?

TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES is a medical device that received FDA 510(k) clearance on 1998-10-21. The listed applicant is Biomet, Inc.. The 510(k) number is K982953.

When did TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES receive FDA 510(k) clearance?

TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES received FDA 510(k) clearance on 1998-10-21, under 510(k) number K982953.

Who is the listed applicant for TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES?

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 TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES?

The FDA product code for TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES is HSB.

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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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