Medtronic Resuable Instruments

FDA UDI

Class I (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: Medtronic Resuable Instruments FDA UDI
Generic Name: Manual orthopaedic bender, reusable FDA UDI
Device Name: BENDER EX0517061 LNG CRNL PLN LF 5.5/6.0 FDA UDI
Model / Reference: EX0517061 FDA UDI
Description: BENDER EX0517061 LNG CRNL PLN LF 5.5/6.0 FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000009304 FDA UDI
FDA Product Code: HXW FDA UDI
GMDN Term: Manual orthopaedic bender, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual orthopaedic bender, reusable

Medtronic Resuable Instruments by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual orthopaedic bender, reusable.

MESA Small Stature Spinal System — K2M, INC. · Class I
Invictus — ALPHATEC SPINE, INC. · Class I
Kestrel® — Innovasis, Inc. · Class II
Surgical Instrument — OSTEONIC CO., Ltd. · Class I
Invictus — ALPHATEC SPINE, INC. · Class I
Dark Star Deformity — Republic Spine, LLC · Class II
g Source — GSOURCE, LLC. · Class I
CLAW CHARLOTTE — WRIGHT MEDICAL TECHNOLOGY, INC. · 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: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI 7c9b5498-ac24-4389-bd89-dda85c67083f 34 fields · synced May 30, 2026