Identity
- Trade Name
- Pediatric Nailing Platform Femur FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- 4.5mm x 100mm Fully Threaded Interlocking Screw, 3.8mm Core FDA UDI
- Model / Reference
- 00-1506-2100 FDA UDI
- Description
- 4.5mm x 100mm Fully Threaded Interlocking Screw, 3.8mm Core FDA UDI
Identifiers
- Catalog Number
- 00-1506-2100 FDA UDI
- Primary DI / UDI-DI
- 00840194415750 FDA UDI
- 510(k) Number
- K220679 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Pediatric Nailing Platform Femur by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- 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
K220679 also covers:
- Pediatric Nailing Platform Femur — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform Femur — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform Femur — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform Femur — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform Femur — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform Femur — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform Femur — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform Femur — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform Femur — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform Femur — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform Femur — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform Femur — 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 24a44336-b1ce-4137-9e81-b3fa007ea138 36 fields · synced Jun 8, 2026