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K2M General Instruments

FDA UDI

Class I (US FDA UDI)

by K2m, Inc.

Identity

Trade Name
K2M General Instruments FDA UDI
Generic Name
Lumbar interspinous decompression instrument set, reusable FDA UDI
Device Name
Split Tube Retractor Ø16x110 mm FDA UDI
Model / Reference
PRO-1414-29 FDA UDI
Description
Split Tube Retractor Ø16x110 mm FDA UDI

Identifiers

Catalog Number
PRO-1414-29 FDA UDI
Primary DI / UDI-DI
10888857581241 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Lumbar interspinous decompression instrument set, 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

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

Dimensions & Sizes

Size
Outer Diameter — 16 Millimeter FDA UDI
Length — 110 Millimeter FDA UDI

Category: Lumbar interspinous decompression instrument set, reusable

K2M General Instruments by K2m, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lumbar interspinous decompression instrument set, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
K2m, Inc.

Sources (1)

  • FDA UDI 18897d72-4d66-49e4-918b-00576dc4143d 36 fields · synced May 30, 2026