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MESA® Spinal System

FDA UDI

Class II (US FDA UDI)

by K2m, Inc.

Identity

Trade Name
MESA® Spinal System FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
Transverse Connector, Rail-Rail Adjustable Size (XL) MESA Rail™-Rail FDA UDI
Model / Reference
801-76590HH FDA UDI
Description
Transverse Connector, Rail-Rail Adjustable Size (XL) MESA Rail™-Rail FDA UDI

Identifiers

Catalog Number
801-76590HH FDA UDI
Primary DI / UDI-DI
10888857142633 FDA UDI
FDA Product Code
MNH FDA UDI
OSH FDA UDI
KWQ FDA UDI
KWP FDA UDI
MNI FDA UDI
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3060 FDA UDI
888.3050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 5.5 Millimeter FDA UDI

Category: Bone-screw internal spinal fixation system connector

MESA® Spinal System by K2m, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
K2m, Inc.

Sources (1)

  • FDA UDI 106de3f9-6b22-4de2-ac38-c5e740b6a055 36 fields · synced May 30, 2026