Precontoured Rod Ø5.5 mm x60 mm Package

FDA UDI

Class II (US FDA UDI)

by Xenco Medical Llc

Identity

Trade Name: Precontoured Rod Ø5.5 mm x60 mm Package FDA UDI
Generic Name: Bone-screw internal spinal fixation system rod FDA UDI
Model / Reference: XM-215-1060 FDA UDI

Identifiers

Primary DI / UDI-DI: B064XM21510601 FDA UDI
FDA Product Code: MNI FDA UDI
MNH FDA UDI
KWQ FDA UDI
NKB FDA UDI
GMDN Term: Bone-screw internal spinal fixation system rod FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

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

Sterilization Method

Radiation Sterilization FDA UDI

Category: Bone-screw internal spinal fixation system rod

Precontoured Rod Ø5.5 mm x60 mm Package by Xenco Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bone-screw internal spinal fixation system rod.

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Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II

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: Xenco Medical Llc

Sources (1)

FDA UDI afb93567-e4cc-4943-9730-0ab8a8e81453 33 fields · synced May 30, 2026