Unity A

by Dio Medical Co., Ltd. 198 variants

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 23 Oct 2026

Documents

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08800039823678 UDI-DI	Date19 Jul 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK173201	Date26 Apr 2018Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Unity
Generic name: Orthopaedic bone wire
Model / Ref / Catalog: A, SI.IN.0001
Description: SIJ K wire sharp threaded (2.4mm OD)

Primary DI / UDI-DI: 08800039823678
510(k) Number: K173201
FDA product code: OUR
GMDN term: Orthopaedic bone wire

Device class: Class II
Regulation number: 888.3040
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization
MRI safety: MR Unsafe

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Properties

Sterilise before use
Single use
Prescription use
Lot / batch number
Manufacturing date

Other properties (10)

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