Caliber Intramedullary Fixation System

FDA UDI

Class II (US FDA UDI)

by Nvision Biomedical Technologies, Inc

Identity

Trade Name: Caliber Intramedullary Fixation System FDA UDI
Generic Name: Clavicle intramedullary nail-like rod FDA UDI
Device Name: 5.0mm implant 80mm long. The Caliber Intramedullary Fixation System is an intramedullary bone fixation screw system used to repair an acute fracture, mal-union or non-union of the clavicle. The intramedullary implant consists of a cannulated screw with distal and proximal threads, a cross-screw receiving hole and a screw head. The diameter ranges from 4.5mm to 5.0mm in lengths from 50mm to 120mm. FDA UDI
Model / Reference: CLN-50-80 FDA UDI
Description: 5.0mm implant 80mm long. The Caliber Intramedullary Fixation System is an intramedullary bone fixation screw system used to repair an acute fracture, mal-union or non-union of the clavicle. The intramedullary implant consists of a cannulated screw with distal and proximal threads, a cross-screw receiving hole and a screw head. The diameter ranges from 4.5mm to 5.0mm in lengths from 50mm to 120mm. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810135962995 FDA UDI
510(k) Number: K242896 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Clavicle intramedullary nail-like rod FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 80 Millimeter FDA UDI
Outer Diameter — 5.0 Millimeter FDA UDI

Category: Clavicle intramedullary nail-like rod

Caliber Intramedullary Fixation System by Nvision Biomedical Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Clavicle intramedullary nail-like rod.

AOS CLAVICLE INTRAMEDULLARY DEVICE 4.0mm x 90mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
ANSER Clavicle Pin — Baat Medical Products B.V. · Class II
AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 90mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 120mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
ANSER Clavicle Pin — Baat Medical Products B.V. · Class II
AOS CLAVICLE INTRAMEDULLARY DEVICE 4.0mm x 80mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
AOS CLAVICLE INTRAMEDULLARY DEVICE 4.0mm x 110mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 80mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II

Cleared under the same submission

K242896 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: Nvision Biomedical Technologies, Inc

Sources (1)

FDA UDI 7730dac3-e366-43e4-8f00-8ff235e22d23 36 fields · synced May 31, 2026