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Aptus A-4655.03

by Medartis Inc.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

Recall on shared 510(k) K091479; other models may be affected

Documents

510(k) K091479

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07630008402235 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK091479 Date13 Jul 2009DecidedStatusActive

Official records

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1550-2026 FDA Class II initiated 9 Jan 2026 on shared 510(k) K091479

    Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

    • Ongoing Z-1821-2024 FDA Class II initiated 12 Apr 2024 on shared 510(k) K091479

    Screw is 16mm long instead of 22mm long.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aptus
Generic name
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Model / Ref / Catalog
A-4655.03
Primary DI / UDI-DI
07630008402235
510(k) Number
FDA product code
HRS
GMDN term
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Cleared under the same submission (K091479)

Show all (12)

Other devices from Medartis Inc.

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    Class II

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    Class II

  • Avenger M70HC022

    Class II

  • Avenger M70HC024

    Class II

  • Avenger M70HC118

    Class II

  • Avenger M70HC120

    Class II

See all devices from Medartis Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number

Other properties (11)

  • Supplied sterile: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No