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Medart 620

by Medart A/S

510(k) K120573

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK120573 Date13 Jun 2012ClearedStatusActive

Official records

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  • Withdrawn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
GEX
Device class
Class II
Regulation
21 CFR Part 878.4810
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Medart 620 is a suture anchor designed for use in orthopaedic and plastic surgery procedures. It provides secure fixation of soft tissue or tendon to bone, utilising a self-drilling and self-tapping mechanism to minimise trauma during implantation.

This device is supplied as a sterile, single-use product and is intended for use in surgical settings. It is classified under product code GEX and has received FDA 510(k) clearance as substantially equivalent under the Special 510(k) Review Program. Storage and handling must comply with standard surgical instrument protocols to maintain sterility and functionality.

Devices cleared under K120573

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K120573
UDI-DISize and differences
MedArt Intenz MedArt 620
Medart A/S
620.000 / MedArt 62005700002070609
Weight 20 kg; Height 20 cm; Length 60 cm; Depth 45 cm
On the market

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from Medart A/S