Identity
- Trade Name
- JUNIORTHO PLATING SYSTEM FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- JPS SS 5.0MM PROXIMAL FEMUR PLATE 110° - 4 HOLES 6MM OFFSET STERILE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- JPS SS 5.0MM PROXIMAL FEMUR PLATE 110° - 4 HOLES 6MM OFFSET STERILE FDA UDI
Identifiers
- Catalog Number
- 99-5431026 FDA UDI
- Primary DI / UDI-DI
- 18053800896228 FDA UDI
- 510(k) Number
- K200246 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 5.0 Millimeter FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
Juniortho Plating System by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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Cleared under the same submission
K200246 also covers:
- JUNIORTHO PLATING SYSTEM — Orthofix, Inc.
- JUNIORTHO PLATING SYSTEM — Orthofix, Inc.
- JUNIORTHO PLATING SYSTEM — Orthofix, Inc.
- JUNIORTHO PLATING SYSTEM — Orthofix, Inc.
- JUNIORTHO PLATING SYSTEM — Orthofix, Inc.
- JUNIORTHO PLATING SYSTEM — Orthofix, Inc.
- JUNIORTHO PLATING SYSTEM — Orthofix, Inc.
- JUNIORTHO PLATING SYSTEM — Orthofix, Inc.
- JUNIORTHO PLATING SYSTEM — Orthofix, Inc.
- JUNIORTHO PLATING SYSTEM — Orthofix, Inc.
- JUNIORTHO PLATING SYSTEM — Orthofix, Inc.
- JUNIORTHO PLATING SYSTEM — Orthofix, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orthofix, Inc.
Sources (1)
- FDA UDI 6a42debd-97ec-4a8e-8dd3-a98451462d55 37 fields · synced May 31, 2026