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OrthoPediatrics PediFoot Deformity Correction System
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- OrthoPediatrics PediFoot Deformity Correction System FDA UDI
- Generic Name
- Osteotomy guide, reusable FDA UDI
- Device Name
- In-Line Cut Guide, Small FDA UDI
- Model / Reference
- 01-1007-0017 FDA UDI
- Description
- In-Line Cut Guide, Small FDA UDI
Identifiers
- Catalog Number
- 01-1007-0017 FDA UDI
- Primary DI / UDI-DI
- 00841132159187 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Osteotomy guide, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Osteotomy guide, reusable
OrthoPediatrics PediFoot Deformity Correction System by Orthopediatrics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Osteotomy guide, reusable.
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- QUANTUM — IN2BONES · Class I
- Cut Guide — TREACE MEDICAL CONCEPTS, INC. · Class I
- UKNEE™ — UNITED ORTHOPEDIC CORP. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Orthopediatrics Corp.
Sources (1)
- FDA UDI e4cf8af0-a5b1-426e-94b6-821f6ece70c6 35 fields · synced Jun 8, 2026