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FDA 510(k)

INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000

K-Number: K051362 · 2005-08-04

ApplicantInion OY
Decision Date2005-08-04
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000 is the device name listed in this FDA 510(k) record. The listed applicant is Inion OY. It received FDA 510(k) clearance on 2005-08-04 under 510(k) number K051362. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000?

INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000 is a medical device that received FDA 510(k) clearance on 2005-08-04. The listed applicant is Inion OY. The 510(k) number is K051362.

When did INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000 receive FDA 510(k) clearance?

INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000 received FDA 510(k) clearance on 2005-08-04, under 510(k) number K051362.

Who is the listed applicant for INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000?

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

What is the FDA product code for INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000?

The FDA product code for INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000 is MAI.

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Other records listing Inion OY 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.

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Related Devices (Code: MAI)

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.

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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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