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FDA 510(k)

SUBTALAR IMPLANT

K-Number: K071498 · 2007-07-31

ApplicantBiomet Sports Medicine, Inc.
Decision Date2007-07-31
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUBTALAR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Sports Medicine, Inc.. It received FDA 510(k) clearance on 2007-07-31 under 510(k) number K071498. 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 SUBTALAR IMPLANT?

SUBTALAR IMPLANT is a medical device that received FDA 510(k) clearance on 2007-07-31. The listed applicant is Biomet Sports Medicine, Inc.. The 510(k) number is K071498.

When did SUBTALAR IMPLANT receive FDA 510(k) clearance?

SUBTALAR IMPLANT received FDA 510(k) clearance on 2007-07-31, under 510(k) number K071498.

Who is the listed applicant for SUBTALAR IMPLANT?

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

What is the FDA product code for SUBTALAR IMPLANT?

The FDA product code for SUBTALAR IMPLANT is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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Other records listing Biomet Sports Medicine, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071816HARPOON SUTURE ANCHORK071704SLEEVE AND BUTTON SOFT TISSUE DEVICESK070389PEEK KNOTLESS ANCHORS

Related Devices (Code: HWC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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