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Suture Anchors - HTA Headless Titanium Anchor And Zip Anchors

by Gm Dos Reis Industria E Comerico Ltda.

510(k) K223114

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 NumberK223114 Date2 Aug 2023ClearedStatusActive

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  • Withdrawn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, 28 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 Suture Anchors - Hta Headless Titanium Anchor and Zip Anchors are orthopedic devices used for suture or tissue fixation. They are manufactured with titanium and are designed to be used in various parts of the body, including the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip.

The Suture Anchors - Hta Headless Titanium Anchor and Zip Anchors are supplied with a catalog number of 315-35-01-10 and are in commercial distribution. They have been cleared with an FDA 510K authorization, with a decision code of SESE, indicating substantial equivalence. The devices are manufactured by Gm Dos Reis Industria E Comerico Ltda.

Other devices from Gm Dos Reis Industria E Comerico Ltda.

Questions

AI-generated answers, 28 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 are the Suture Anchors used for?

    The Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors are used for suture or tissue fixation in various parts of the body, including the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip, due to their design and titanium material.

  • How are the Suture Anchors supplied?

    The Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors are supplied with a catalog number of 315-35-01-10 and are in commercial distribution, allowing for easy access and procurement.

  • What is the material of the Suture Anchors?

    The Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors are manufactured with titanium, which provides strength, durability, and biocompatibility for orthopedic applications.

  • What regulatory authorization do the Suture Anchors have?

    The Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors have been cleared with an FDA 510K authorization, indicating substantial equivalence to existing devices, with a decision code of SESE.