Identity
- Trade Name
- FASSIER-DUVAL TELESCOPIC IM SYSTEM FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- FULL 2.8mm PEG CADDY FDA UDI
- Model / Reference
- FD-PEG-CFL-28 FDA UDI
- Description
- FULL 2.8mm PEG CADDY FDA UDI
Identifiers
- Catalog Number
- FD-PEG-CFL-28 FDA UDI
- Primary DI / UDI-DI
- 07540194017765 FDA UDI
- 510(k) Number
- K041393 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
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Fassier-Duval Telescopic Im System by Orthopediatrics Canada ULC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
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- Arthrex® — Arthrex, Inc. · Class II
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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
K041393 also covers:
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
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 Canada ULC
Sources (1)
- FDA UDI 306125f3-09d9-4316-9ff2-2bfb70567e39 36 fields · synced May 30, 2026