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Fassier-Duval Telescopic Im System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref FD-064(SPS)-SSModel NAIL IMPLANT
Identity
- Trade Name
- The Fassier-Duval Telescopic IM System EUDAMEDFASSIER-DUVAL TELESCOPIC IM SYSTEM FDA UDI
- Generic Name
- Arthrodesis intramedullary nail, non-distracting FDA UDI
- Device Name
- Short Tibial/Humeral Nail Assy Ø6.4mm x 407mm FDA UDI
- Model / Reference
- FD-064(SPS)-SS EUDAMEDFDA UDINAIL IMPLANT EUDAMED
- Description
- Short Tibial/Humeral Nail Assy Ø6.4mm x 407mm FDA UDI
Identifiers
- Catalog Number
- FD-064(SPS)-SS FDA UDI
- Primary DI / UDI-DI
- 07540194000538 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194FD-NAILSM7 EUDAMED
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS EUDAMED
- GMDN Term
- Arthrodesis intramedullary nail, non-distracting FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Dimensions & Sizes
- Size
- Outer Diameter — 6.4 Millimeter FDA UDILength — 407 Millimeter FDA UDI
Category: Arthrodesis intramedullary nail, non-distracting
Fassier-Duval Telescopic Im System by Orthopediatrics Canada ULC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- Reconstruction nail; long, 12×320 mm, 135°, left, cannulated — MEDIN, a.s. · Class IIb
- ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ — Zimed Medikal Sanayi ve Ticaret Limited Şirketi · Class IIb
- INTREX — Bonetech Medisys Pvt. Ltd. · Class IIb
- Locking Screw — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- Ankle Compression Nailing System — Orthofix, Inc. · Class II
- Femoral Nail — WUHAN MINDRAY SCIENTIFIC CO., LTD. · Class IIb
Cleared under the same submission
K020885 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
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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (2)
- FDA UDI c0ab7927-6b54-4bdc-9df1-17710d976c21 38 fields · synced Jun 11, 2026
- EUDAMED 71a0f815-42d0-47e6-a675-ff66cea4095f 61 fields · synced Jun 11, 2026