Juniortho Plating System 1
Juniortho Plating System 1 (99-5433001) 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 18053800896433), active as of 12 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number18053800896433 | Date3 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200246 | Date22 May 2020 | StatusActive |
Official records
- AccessGUDID record 18053800896433
- FDA 510(k) database K200246
Across registries
- FDA 510(k) K200246 decided 22 May 2020 Active
- FDA GUDID UDI-DI 18053800896433 listed 3 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K200246
- Listed FDA GUDID 18053800896433
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Juniortho Plating System
- Generic name
- Orthopaedic fixation plate, non-bioabsorbable
- Model / Ref / Catalog
- 1, 99-5433001
- Primary DI / UDI-DI
- 18053800896433
- 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 — 3.5 Millimeter
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