Juniortho Plating System 1
Juniortho Plating System 1 (5413060) is an orthopaedic bone screw (FDA Class II; FDA product code HWC, Screw, Fixation, Bone) made by Orthofix SRL, cleared under FDA 510(k) K200246 on 22 May 2020 and listed in FDA GUDID since 1 Jul 2020 (UDI-DI 18053800899946), 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 | Number18053800899946 | Date1 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200246 | Date22 May 2020 | StatusActive |
Official records
- AccessGUDID record 18053800899946
- FDA 510(k) database K200246
Across registries
- FDA 510(k) K200246 decided 22 May 2020 Active
- FDA GUDID UDI-DI 18053800899946 listed 1 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K200246
- Listed FDA GUDID 18053800899946
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Juniortho Plating System
- Generic name
- Orthopaedic bone screw, non-bioabsorbable, sterile
- Model / Ref / Catalog
- 1, 5413060
- Primary DI / UDI-DI
- 18053800899946
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Orthopaedic bone screw, non-bioabsorbable, sterile
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Width — 107 Millimeter
Similar devices in this category
Other devices filed under Orthopaedic bone screw, non-bioabsorbable, sterile.
- NON-LOCK SCREW SQUARE DRIVE 131827220 by Biomet Orthopedics, Inc.
- PEG FULLY THREADED, LOCKING 1312-12-610 131212610 by Biomet Orthopedics, Inc.
- ACUMED AT2-C08-S by ACUMED LLC
- ACUMED AT2-C12-S by ACUMED LLC
- Mpact Extension 01.43.0035 by Medacta International SA
- 6250-65-35 00-6250-065-35 by Zimmer, Inc.
- OsteoMed 337-3526-SP-02 by Osteomed Corp.
- Trinity Acetabular Hip System 321.055 by CORIN LTD
- 6624-65-60 00-6624-065-60 by Zimmer, Inc.
- Versafitcup CC TRIO Acetabular System 01.26.65.25 by Medacta International SA