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Opus Magnum Knotless Anchor With Inserter Handle

by Opus Medical, Inc.

510(k) K042914

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK042914 Date12 Nov 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Opus Magnum Knotless Anchor With Inserter Handle is a bone fixation fastener used for soft tissue-to-bone attachment. It is a type of fastener, fixation, nondegradable, soft tissue device. The device consists of an anchor and an inserter tool.

The Opus Magnum Knotless Anchor With Inserter Handle is supplied with an inserter handle and is used for fixation of soft tissue to bone for rotator cuff repair. It is classified as a Class II device with special controls and has been cleared under FDA 510(k) number K042914.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Opus Magnum Knotless Anchor used for?

    The Opus Magnum Knotless Anchor is used for fixation of soft tissue to bone, specifically for rotator cuff repair.

  • Is the Opus Magnum Knotless Anchor supplied with any additional tools?

    Yes, the Opus Magnum Knotless Anchor is supplied with an inserter handle.

  • What type of device is the Opus Magnum Knotless Anchor classified as?

    The Opus Magnum Knotless Anchor is classified as a Class II device with special controls.