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Juniortho Plating System 1

by Orthofix SRL 340 variants

Juniortho Plating System 1 (99-5431035) is an orthopaedic fixation plate (FDA Class II; FDA product code HRS, Plate, Fixation, Bone) made by Orthofix SRL, cleared under FDA 510(k) K200246 on 22 May 2020 and listed in FDA GUDID since 3 Jul 2020 (UDI-DI 18053800896310), active as of 12 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 12 Nov 2026

Documents

510(k) K200246

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number18053800896310 UDI-DI Date3 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK200246 Date22 May 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200246 decided 22 May 2020 Active
  • FDA GUDID UDI-DI 18053800896310 listed 3 Jul 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200246
  2. Listed FDA GUDID 18053800896310

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Juniortho Plating System
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
1, 99-5431035
Primary DI / UDI-DI
18053800896310
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
Lumen/Inner Diameter — 5.0 Millimeter

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K200246)

and 8 more cleared under K200246

Similar devices in this category

Other devices filed under Orthopaedic fixation plate, non-bioabsorbable.

Other devices from Orthofix SRL

See all devices from Orthofix SRL →

Properties

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