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OrthoPediatrics PediNail Intramedullary Nailing System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- OrthoPediatrics PediNail Intramedullary Nailing System FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- 4.5MM x 20MM CORTICAL SCREW FDA UDI
- Model / Reference
- 10-1500-3020 FDA UDI
- Description
- 4.5MM x 20MM CORTICAL SCREW FDA UDI
Identifiers
- Catalog Number
- 10-1500-3020 FDA UDI
- Primary DI / UDI-DI
- 00841132118177 FDA UDI
- 510(k) Number
- K083726 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone screw (non-sliding)
OrthoPediatrics PediNail Intramedullary Nailing System by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw (non-sliding).
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- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K083726 also covers:
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
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
- Orthopediatrics Corp.
Sources (1)
- FDA UDI b936f18e-6280-4b20-bf01-24ffd8c9a13e 36 fields · synced May 31, 2026