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Radian MIS Bunion System BUN-PLT-05

by Nvision Biomedical Technologies, Inc

Radian MIS Bunion System BUN-PLT-05 is a Class II device made by Nvision Biomedical Technologies, Inc, cleared under FDA 510(k) K211650 on 24 Nov 2021 and listed in FDA GUDID since 1 Feb 2022 (UDI-DI 00810005665704), 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) K211650

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 Number00810005665704 UDI-DI Date1 Feb 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK211650 Date24 Nov 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211650 decided 24 Nov 2021 Active
  • FDA GUDID UDI-DI 00810005665704 listed 1 Feb 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211650
  2. Listed FDA GUDID 00810005665704

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Radian MIS Bunion System
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Model / reference
BUN-PLT-05
Primary DI / UDI-DI
00810005665704
510(k) Number
FDA product code
HRS
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Height — 5.0 Millimeter

Related devices

Cleared under the same submission (K211650)

Other devices from Nvision Biomedical Technologies, Inc

See all devices from Nvision Biomedical Technologies, Inc →

Properties

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