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FDA 510(k)

SYNTHES 6.5MM MIDFOOT FUSION BOLT

K-Number: K081071 · 2008-05-01

ApplicantSynthes (Usa)
Decision Date2008-05-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES 6.5MM MIDFOOT FUSION BOLT is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2008-05-01 under 510(k) number K081071. 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 SYNTHES 6.5MM MIDFOOT FUSION BOLT?

SYNTHES 6.5MM MIDFOOT FUSION BOLT is a medical device that received FDA 510(k) clearance on 2008-05-01. The listed applicant is Synthes (Usa). The 510(k) number is K081071.

When did SYNTHES 6.5MM MIDFOOT FUSION BOLT receive FDA 510(k) clearance?

SYNTHES 6.5MM MIDFOOT FUSION BOLT received FDA 510(k) clearance on 2008-05-01, under 510(k) number K081071.

Who is the listed applicant for SYNTHES 6.5MM MIDFOOT FUSION BOLT?

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

What is the FDA product code for SYNTHES 6.5MM MIDFOOT FUSION BOLT?

The FDA product code for SYNTHES 6.5MM MIDFOOT FUSION BOLT is HWC. This falls under the Cardiovascular category.

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Other records listing Synthes (Usa) as applicant

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Related Devices (Code: HWC)

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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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