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Rigidfix
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 213721Model General Orthopedic Use Rods and Aimers
Identity
- Trade Name
- RIGIDFIX Femoral Rod EUDAMEDRIGIDFIX FDA UDI
- Generic Name
- Orthopaedic guidewire, reusable FDA UDI
- Device Name
- Rigidfix, Femoral, Rod, Restore, Aimer, Tibial, Guide EUDAMEDRIGIDFIX Femoral Rod Bone Tendon Bone Only 11.5mm, 30-120mm (Plus or Minus 6 Percent) FDA UDI
- Model / Reference
- 213721 EUDAMEDFDA UDIGeneral Orthopedic Use Rods and Aimers EUDAMED
- Description
- RIGIDFIX Femoral Rod Bone Tendon Bone Only 11.5mm, 30-120mm (Plus or Minus 6 Percent) FDA UDI
Identifiers
- Catalog Number
- 213721 FDA UDI
- Primary DI / UDI-DI
- 10886705003129 EUDAMEDFDA UDI
- Basic UDI-DI
- 0886705a00155KM EUDAMED
- Direct Marketing DI
- 10886705003129 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Orthopaedic guidewire, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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
Yes
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
Category: Orthopaedic guidewire, reusable
Rigidfix by Medos International Sàrl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic guidewire, reusable.
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- Guide Wire — I.T.S. GmbH · Class I
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- ZERO-P — Synthes GmbH · Class IIa
- Guidewire, Nitinol, Double Blunt, 1.19 x 610mm — Captiva Spine · Class I
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medos International Sàrl
Sources (2)
- FDA UDI eba8a68b-b375-4c0c-9cde-5d1aace87618 35 fields · synced Jun 19, 2026
- EUDAMED d96472f0-5848-4f3e-9aa7-e3b5b74e17f4 61 fields · synced Jun 19, 2026