FDA 510(k)

BEAR®（ブリッジ強化ACL回復）イムプラント

K番号: K251214 · 2026-01-13

決定日2026-01-13

製品コードQNI

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

BEAR® (Bridge-Enhanced ACL Restoration) Implant is the device name listed in this FDA 510(k) record. The listed applicant is Miach Orthopaedics, Inc.. It received FDA 510(k) clearance on 2026-01-13 under 510(k) number K251214. The device is classified under product code QNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the BEAR® (Bridge-Enhanced ACL Restoration) Implant?

BEAR® (Bridge-Enhanced ACL Restoration) Implant is a medical device that received FDA 510(k) clearance on 2026-01-13. The listed applicant is Miach Orthopaedics, Inc.. The 510(k) number is K251214.

When did BEAR® (Bridge-Enhanced ACL Restoration) Implant receive FDA 510(k) clearance?

BEAR® (Bridge-Enhanced ACL Restoration) Implant received FDA 510(k) clearance on 2026-01-13, under 510(k) number K251214.

Who is the listed applicant for BEAR® (Bridge-Enhanced ACL Restoration) Implant?

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

What is the FDA product code for BEAR® (Bridge-Enhanced ACL Restoration) Implant?

The FDA product code for BEAR® (Bridge-Enhanced ACL Restoration) Implant is QNI.

申請者としてMiach Orthopaedics, Inc.を記載するその他の記録

K243578BEAR®（ブリッジ強化ACL回復）イムプラント

公式ソース

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