Iva

by Dio Medical Co., Ltd. 221 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 21 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 21 Oct 2026. What this means

Regulatory status

as of registry sync 21 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08809489297855 UDI-DI	Date8 May 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK162220	Date21 Nov 2016Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 21 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Bone-screw internal spinal fixation system, non-sterile
Model / Ref / Catalog: A, AL.0534

Primary DI / UDI-DI: 08809489297855
510(k) Number: K162220
FDA product code: ODP, MAX
GMDN term: Bone-screw internal spinal fixation system, non-sterile

Device class: Class II
Regulation number: 888.3080
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