Rondo'

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name: RONDO' FDA UDI
Generic Name: Orthopaedic bone washer, sterile FDA UDI
Device Name: ø16mm washer for ø6.5-7.5mm screw. Material: titanium alloy Ti6Al4V ELI (ASTM F136). FDA UDI
Model / Reference: Washer ø16mm FDA UDI
Description: ø16mm washer for ø6.5-7.5mm screw. Material: titanium alloy Ti6Al4V ELI (ASTM F136). FDA UDI

Identifiers

Catalog Number: VT-65000 FDA UDI
Primary DI / UDI-DI: 08032909629565 FDA UDI
510(k) Number: K113388 FDA UDI
FDA Product Code: HTY FDA UDI
HTN FDA UDI
HWC FDA UDI
GMDN Term: Orthopaedic bone washer, sterile 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

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 — 16 Millimeter FDA UDI

Category: Orthopaedic bone washer, sterile

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

Similar devices

Also classified as Orthopaedic bone washer, sterile.

BITE COMPRESSION SCREWS — Orthofix, Inc. · Class II
TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
FLAT WASHER6.5MM — Biomet Orthopedics, Inc. · Class II
TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
SURFIX — Newdeal Sas · Class II
SURFIX — Newdeal Sas · Class II
SURFIX Alpha — Newdeal Sas · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Citieffe

Sources (1)

FDA UDI b28d8b5b-57a7-414b-9ae0-57fc96d81c06 38 fields · synced May 30, 2026