Bone Clamp

FDA UDI

Class I (US FDA UDI)

by Koros USA, Inc.

Identity

Trade Name: Bone Clamp FDA UDI
Generic Name: Bone approximation clamp FDA UDI
Device Name: Side Angled Bone Clamp 11.5mm Jaw, 10-1/2" 25.5cm Length FDA UDI
Model / Reference: 7791-46 FDA UDI
Description: Side Angled Bone Clamp 11.5mm Jaw, 10-1/2" 25.5cm Length FDA UDI

Identifiers

Catalog Number: 7791-46 FDA UDI
Primary DI / UDI-DI: 10840199533173 FDA UDI
FDA Product Code: HXD FDA UDI
GMDN Term: Bone approximation clamp FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone approximation clamp

Bone Clamp by Koros USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone approximation clamp.

Journey II — Smith & Nephew, Inc. · Class II
PERI-LOC VLP — Smith & Nephew, Inc. · Class II
LEGION — Smith & Nephew, Inc. · Class I
PROFIX — Smith & Nephew, Inc. · Class II
Sklar® — Sklar Corporation · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
Symmetry Martin — SYMMETRY SURGICAL INC. · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I

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 I	Pending data

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

Manufacturer

Manufacturer: Koros USA, Inc.

Sources (1)

FDA UDI a69cfd43-3093-4508-b74d-a3ba22c56083 37 fields · synced Jun 8, 2026