Rigidfix

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name: RIGIDFIX FDA UDI
Generic Name: Orthopaedic guidewire, reusable FDA UDI
Device Name: RIGIDFIX CURVE ST Guide Block ST Guide Block FDA UDI
Model / Reference: 213006 FDA UDI
Description: RIGIDFIX CURVE ST Guide Block ST Guide Block FDA UDI

Identifiers

Catalog Number: 213006 FDA UDI
Primary DI / UDI-DI: 10886705019977 FDA UDI
510(k) Number: K130105 FDA UDI
FDA Product Code: MAI FDA UDI
HTY FDA UDI
GMDN Term: Orthopaedic guidewire, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic guidewire, reusable

Rigidfix by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — 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

K130105 also covers:

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: Medos International Sàrl

Sources (1)

FDA UDI 85fe9943-f4c3-4952-b3b4-1b16b214235c 36 fields · synced May 29, 2026