Monkey Rings™ External Fixation System

FDA UDI

Class II (US FDA UDI)

by Paragon 28

Identity

Trade Name: Monkey Rings™ External Fixation System FDA UDI
Generic Name: External orthopaedic fixation system, single-use FDA UDI
Device Name: Monkey Rings, Wire, Ø2.0mm x 400mm, Half Point, Ti FDA UDI
Model / Reference: P45-194-2140 FDA UDI
Description: Monkey Rings, Wire, Ø2.0mm x 400mm, Half Point, Ti FDA UDI

Identifiers

Catalog Number: P45-194-2140 FDA UDI
Primary DI / UDI-DI: 00889795130426 FDA UDI
510(k) Number: K212895 FDA UDI
K232838 FDA UDI
FDA Product Code: KTT FDA UDI
GMDN Term: External orthopaedic fixation system, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

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

MRI Safety

MR Unsafe FDA UDI

Category: External orthopaedic fixation system, single-use

A comprehensive external fixation system designed to stabilize fractured bones and promote treatment and healing. Monkey Rings Wire External Fixation System is a single-use device used mainly to help the healing of long bones, fractures of the foot and ankle, joint fusions, and limb lengthening.

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DRACO — HNM TOTAL RECON LLC · Class II
PREFIX FIXATOR — Orthofix, Inc. · Class II
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SMART TSF — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K232838 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: Paragon 28

Sources (1)

FDA UDI a201b4fd-3be6-4b41-94a9-72be5d61216c 35 fields · synced Jul 9, 2026

Monkey Rings™ External Fixation System

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)