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Iva

by Dio Medical Co., Ltd. 221 variants

Iva (AC.0100) is a Class II device made by Dio Medical Co., Ltd., cleared under FDA 510(k) K162220 on 21 Nov 2016 and listed in FDA GUDID since 8 May 2017 (UDI-DI 08809489298104), active as of 31 May 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 31 May 2026

Documents

510(k) K162220

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 31 May 2026.

Regulatory status

as of registry sync 31 May 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809489298104 UDI-DI Date8 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162220 Date21 Nov 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162220 decided 21 Nov 2016 Active
  • FDA GUDID UDI-DI 08809489298104 listed 8 May 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162220
  2. Listed FDA GUDID 08809489298104

Coverage

1 jurisdiction

United States of America
  • 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  • Withdrawn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, AC.0100
Primary DI / UDI-DI
08809489298104
510(k) Number
FDA product code
MAX, ODP
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

Related devices

Category: Bone-screw internal spinal fixation system, non-sterile

Cleared under the same submission (K162220)

and 8 more cleared under K162220

Other devices from Dio Medical Co., Ltd.

  • Iva

    Class II

  • IVA Cage Ti

    Class II

  • IVA Cage

    Class II

  • Aeon-C

    Class II

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

Properties

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