← Back to catalogue

MESA Small Stature Spinal System

FDA UDI

Class I (US FDA UDI)

by K2m, Inc.

Identity

Trade Name
MESA Small Stature Spinal System FDA UDI
Generic Name
Orthopaedic rod reducer FDA UDI
Device Name
Reduction Jack Rotation Tube FDA UDI
Model / Reference
3001-90106 FDA UDI
Description
Reduction Jack Rotation Tube FDA UDI

Identifiers

Catalog Number
3001-90106 FDA UDI
Primary DI / UDI-DI
10888857053106 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic rod reducer 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

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

Category: Orthopaedic rod reducer

MESA Small Stature Spinal System by K2m, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic rod reducer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
K2m, Inc.

Sources (1)

  • FDA UDI 0f2583ae-08a9-4c4d-913c-db0a3ef465df 35 fields · synced Jun 8, 2026