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PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor - 10-1629-01

by Smith & Nephew, Inc.

510(k) K152566

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 · Traditional NumberK152566 Date2 Dec 2015ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0581-2025 FDA Class II initiated 29 Oct 2024

    Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

    • Terminated Z-1273-2020 FDA Class II initiated 30 Dec 2019

    Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.

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  • Withdrawn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
Models / Variants
10-1629-01
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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