Skip to content

MectaLock Extension

by Medacta International S.A.

510(k) K203493

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 NumberK203493 Date22 Feb 2021ClearedStatusActive

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  • Withdrawn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
MAI
Device Class
Class II
Regulation
21 CFR Part 888.3030
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 MectaLock Extension is a biodegradable soft tissue fastener classified as a Class II orthopedic device under product code MAI. It is a metallic bone fixation fastener designed for use in orthopedic procedures to secure soft tissue to bone.

The device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance K203493, with a traditional pathway decision date of February 22, 2021, and is classified under regulation number 888.3030.

Other devices from Medacta International S.A.

See all devices from Medacta International S.A. →