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Eba One

by Citieffe 13 variants

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 31 May 2026

Documents

510(k) K183666

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 31 May 2026. What this means

Regulatory status

as of registry sync 31 May 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08059386741986 UDI-DI Date26 Jun 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK183666 Date14 Nov 2019DecidedStatusActive

Official records

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 31 May 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
Eba One static cephalic screw ø10.5mm L80mm, EBA-586080
Primary DI / UDI-DI
08059386741986
510(k) Number
FDA product code
HSB
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class II
Regulation number
888.3020
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K183666)

Show all (12)

Other devices from Citieffe

See all devices from Citieffe →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date

Other properties (8)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No