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FDA 510(k)

METASURG SUBTALAR IMPLANT

K-Number: K111265 · 2011-08-09

ApplicantMetasurg
Decision Date2011-08-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METASURG SUBTALAR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Metasurg. It received FDA 510(k) clearance on 2011-08-09 under 510(k) number K111265. 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 METASURG SUBTALAR IMPLANT?

METASURG SUBTALAR IMPLANT is a medical device that received FDA 510(k) clearance on 2011-08-09. The listed applicant is Metasurg. The 510(k) number is K111265.

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

METASURG SUBTALAR IMPLANT received FDA 510(k) clearance on 2011-08-09, under 510(k) number K111265.

Who is the listed applicant for METASURG SUBTALAR IMPLANT?

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

What is the FDA product code for METASURG SUBTALAR IMPLANT?

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

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Other records listing Metasurg 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.

K123926METASURG NITINOL STAPLE IMPLANTK111536METASURG DIGIFUSE IMPLANTK083469METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000K070441METASURG SUBTALAR IMPLANT

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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