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Rigidfix
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 213004Model Rigidfix Curve Cross Pin System, Aiming and Guiding Instruments
Identity
- Trade Name
- RIGIDFIX CURVE GUIDE FRAME EUDAMEDRIGIDFIX FDA UDI
- Generic Name
- Orthopaedic guidewire, reusable FDA UDI
- Device Name
- Rigidfix Curve, Guide Frame, Arc, Guide Block EUDAMEDRIGIDFIX CURVE GUIDE FRAME Guide Frame FDA UDI
- Model / Reference
- 213004 EUDAMEDFDA UDIRigidfix Curve Cross Pin System, Aiming and Guiding Instruments EUDAMED
- Description
- RIGIDFIX CURVE GUIDE FRAME Guide Frame FDA UDI
Identifiers
- Catalog Number
- 213004 FDA UDI
- Primary DI / UDI-DI
- 10886705019953 EUDAMEDFDA UDI
- Basic UDI-DI
- 0886705a00146KL EUDAMED
- Direct Marketing DI
- 10886705019953 EUDAMED
- 510(k) Number
- K130105 FDA UDI
- FDA Product Code
- MAI FDA UDIHTY FDA UDI
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Orthopaedic guidewire, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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
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
Category: Orthopaedic guidewire, reusable
Rigidfix by Medos International Sàrl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic guidewire, reusable.
- Orthopaedic Spreader — Synthes GmbH · Class IIa
- LCP — Synthes GmbH · Class IIa
- Guide Wire — I.T.S. GmbH · Class I
- Parallel Wire Guide, for φ2.5 Guide Wire, Adjustable — Double Medical Technology Inc. · Class II
- VERTECEM — Synthes GmbH · Class IIa
- Adapter Fibre Optic Cable Light Cable — Synthes GmbH · Class I
- ZERO-P — Synthes GmbH · Class IIa
- Guidewire, Nitinol, Double Blunt, 1.19 x 610mm — Captiva Spine · Class I
Cleared under the same submission
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
- Medos International Sàrl
Sources (2)
- FDA UDI ef0f8091-ad08-4c46-aef6-8aaeb605a3fa 36 fields · synced Jul 22, 2026
- EUDAMED 767be26a-52bd-4fd8-9b6f-9712820122bb 61 fields · synced Jul 22, 2026