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FDA 510(k)

SMOOTH OR THREADED METALLIC BONE FASTENER

K-Number: K131640 · 2013-10-16

ApplicantBiomedical Ent., Inc.
Decision Date2013-10-16
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMOOTH OR THREADED METALLIC BONE FASTENER is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Ent., Inc.. It received FDA 510(k) clearance on 2013-10-16 under 510(k) number K131640. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMOOTH OR THREADED METALLIC BONE FASTENER?

SMOOTH OR THREADED METALLIC BONE FASTENER is a medical device that received FDA 510(k) clearance on 2013-10-16. The listed applicant is Biomedical Ent., Inc.. The 510(k) number is K131640.

When did SMOOTH OR THREADED METALLIC BONE FASTENER receive FDA 510(k) clearance?

SMOOTH OR THREADED METALLIC BONE FASTENER received FDA 510(k) clearance on 2013-10-16, under 510(k) number K131640.

Who is the listed applicant for SMOOTH OR THREADED METALLIC BONE FASTENER?

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

What is the FDA product code for SMOOTH OR THREADED METALLIC BONE FASTENER?

The FDA product code for SMOOTH OR THREADED METALLIC BONE FASTENER is HTY.

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Other records listing Biomedical Ent., Inc. as applicant

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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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