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Rose Dorsal Plate 23292

by Biopro, Inc.

Rose Dorsal Plate 23292 is a Class II device made by Biopro, Inc., cleared under FDA 510(k) K162674 on 16 Jun 2017 and listed in FDA GUDID since 27 Oct 2026 (UDI-DI M209232920), active as of 9 Nov 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 9 Nov 2026

Documents

510(k) K162674

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM209232920 UDI-DI Date27 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162674 Date16 Jun 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162674 decided 16 Jun 2017 Active
  • FDA GUDID UDI-DI M209232920 listed 27 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162674
  2. Listed FDA GUDID M209232920

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rose Dorsal Plate
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Model / reference
23292
Primary DI / UDI-DI
M209232920
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

Related devices

Cleared under the same submission (K162674)

and 8 more cleared under K162674

Other devices from Biopro, Inc.

See all devices from Biopro, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)