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Surgical Dynamics S.D. SORB E-Z TAC

by United States Surgical, A Division of Tyco Healthc

510(k) K973281

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 · Traditional NumberK973281 Date3 Nov 1997ClearedStatusActive

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  • Withdrawn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)

Full name
The Surgical Dynamics* S.D. Sorb* E-Z Tac*
510(k) Number
FDA Product Code
MAI
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The Surgical Dynamics S.D. SORB E-Z TAC is an absorbable implant designed for affixing soft tissue to bone. It is used in orthopedic procedures, specifically for rotator cuff repairs and glenoid labrum or inferior glenohumeral ligament reattachment.

The device is supplied as a single-use implant and is not MRI safe. It is regulated as a Class II device with FDA 510K clearance under product code MAI. The device is manufactured by United States Surgical, A Division of Tyco Healthcare, and is stored according to the manufacturer's instructions.

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Questions

AI-generated answers, 26 Sep 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 S.D. SORB E-Z TAC implant used for?

    The S.D. SORB E-Z TAC is an absorbable implant designed for affixing soft tissue to bone. It is specifically used in orthopedic procedures for rotator cuff repairs and glenoid labrum or inferior glenohumeral ligament reattachment.

  • Is the S.D. SORB E-Z TAC implant single-use or reusable?

    The device is supplied as a single-use implant, meaning it should be used only once and then discarded. It is not designed for reuse in multiple procedures.

  • What are the storage requirements for the S.D. SORB E-Z TAC implant?

    The S.D. SORB E-Z TAC implant should be stored according to the manufacturer's instructions. Specific storage conditions are not detailed in the provided information, so users should refer to the product documentation for proper storage guidelines.

  • Is the S.D. SORB E-Z TAC implant MRI safe?

    No, the S.D. SORB E-Z TAC implant is not MRI safe. This means it should not be used in patients who are scheduled to undergo MRI scans, as the device could interfere with the imaging process or potentially cause complications.