Rondo'

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name: RONDO' FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name: Kirschner wire with threaded trocar tip ø1.4x150mm. Material: stainless steel AISI 316L (ASTM F138). FDA UDI
Model / Reference: K wire threaded trocar tip ø1.4x150mm FDA UDI
Description: Kirschner wire with threaded trocar tip ø1.4x150mm. Material: stainless steel AISI 316L (ASTM F138). FDA UDI

Identifiers

Catalog Number: 66414 FDA UDI
Primary DI / UDI-DI: 08056711928920 FDA UDI
510(k) Number: K113388 FDA UDI
FDA Product Code: HTY FDA UDI
HTN FDA UDI
HWC FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 1.4 Millimeter FDA UDI
Length — 150 Millimeter FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable

Rondo' by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone pin, non-bioabsorbable.

Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
KW03-310-18.A — newbox medical GmbH · Class IIb
Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
XtraFix® External Fixation System — Zimmer, Inc. · Class II
CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
SMART TSF — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K113388 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: Citieffe

Sources (1)

FDA UDI 4f7768b7-6ae6-4a5e-950e-09a6ac8b553b 38 fields · synced May 30, 2026