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VERTACONNECT Inserter, spreader

by SIGNUS Medizintechnik GmbH 2 variants

VERTACONNECT Inserter, spreader (CAT4003) is a Class II device made by SIGNUS Medizintechnik GmbH, cleared under FDA 510(k) K203327 on 25 Jan 2021 and listed in FDA GUDID since 25 Jan 2023 (UDI-DI 04047844100929), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K203327

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04047844100929 UDI-DI Date25 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK203327 Date25 Jan 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203327 decided 25 Jan 2021 Active
  • FDA GUDID UDI-DI 04047844100929 listed 25 Jan 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203327
  2. Listed FDA GUDID 04047844100929

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vertaconnect
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
Inserter, spreader, CAT4003
Primary DI / UDI-DI
04047844100929
510(k) Number
FDA product code
MAX
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Cleared under the same submission (K203327)

and 8 more cleared under K203327

Similar devices in this category

Other devices filed under Orthopaedic surgical procedure kit, non-medicated, reusable.

Other devices from SIGNUS Medizintechnik GmbH

See all devices from SIGNUS Medizintechnik GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)