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Distal Radius Plate, Narrow, Right, 3 Holes FDR 002

by Flower Orthopedics Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840118109925 UDI-DI Date13 Mar 2020ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-0034-2022 FDA Class II initiated 3 Sep 2021

    Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)

    • Terminated Z-1314-2015 FDA Class II initiated 16 Feb 2015 on shared 510(k) K123562

    Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Distal Radius Plate, Narrow, Right, 3 Holes
Generic Name
Orthopaedic fixation plate, non-bioabsorbable
Model / Reference
FDR 002
Primary DI / UDI-DI
00840118109925
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
Size
Height — 2.0 Millimeter

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K123562)

Show all (12)

Other devices from Flower Orthopedics Corporation

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No