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Everglade Stem, Standard Offset 111-45-0411

by Signature Orthopaedics Pty Ltd

Everglade Stem, Standard Offset 111-45-0411 is a Class II device made by Signature Orthopaedics Pty Ltd, cleared under FDA 510(k) K211505 on 24 Sep 2021 and listed in FDA GUDID since 19 Aug 2022 (UDI-DI 09348215107093), active as of 23 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 23 Oct 2026

Documents

510(k) K211505

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09348215107093 UDI-DI Date19 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK211505 Date24 Sep 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211505 decided 24 Sep 2021 Active
  • FDA GUDID UDI-DI 09348215107093 listed 19 Aug 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211505
  2. Listed FDA GUDID 09348215107093

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Everglade Stem, Standard Offset
Generic name
Coated hip femur prosthesis, modular
Model / reference
111-45-0411
Primary DI / UDI-DI
09348215107093
510(k) Number
FDA product code
MEH, LZO
GMDN term
Coated hip femur prosthesis, modular
Device class
Class II
Regulation number
888.3353
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coated hip femur prosthesis, modular

Cleared under the same submission (K211505)

and 8 more cleared under K211505

Other devices from Signature Orthopaedics Pty Ltd

See all devices from Signature Orthopaedics Pty Ltd →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)