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Unity Erodium 000E013540

by Dio Medical Co., Ltd.

Unity Erodium 000E013540 is a Class II device made by Dio Medical Co., Ltd., cleared under FDA 510(k) K222448 on 13 Oct 2022 and listed in FDA GUDID since 26 Jun 2023 (UDI-DI 00850051372119), 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) K222448

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 Number00850051372119 UDI-DI Date26 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK222448 Date13 Oct 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222448 decided 13 Oct 2022 Active
  • FDA GUDID UDI-DI 00850051372119 listed 26 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K222448
  2. Listed FDA GUDID 00850051372119

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Unity Erodium
Generic name
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Model / Ref / Catalog
000E013540
Primary DI / UDI-DI
00850051372119
510(k) Number
FDA product code
OUR
GMDN term
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

Cleared under the same submission (K222448)

and 8 more cleared under K222448

Similar devices

Other devices filed under FDA product code OUR (Sacroiliac Joint Fixation).

Other devices from Dio Medical Co., Ltd.

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  • Aeon-C

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See all devices from Dio Medical Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)