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K2M Fenestrated Tap System

FDA UDI

Class II (US FDA UDI)

by K2m, Inc.

Identity

Trade Name
K2M Fenestrated Tap System FDA UDI
Generic Name
Internal spinal fixation procedure kit, single-use FDA UDI
Device Name
Tap, Fenestrated Size Ø7.5 FDA UDI
Model / Reference
PRO-1117-05 FDA UDI
Description
Tap, Fenestrated Size Ø7.5 FDA UDI

Identifiers

Catalog Number
PRO-1117-05 FDA UDI
Primary DI / UDI-DI
10888857530089 FDA UDI
FDA Product Code
KNW FDA UDI
OAR FDA UDI
GMDN Term
Internal spinal fixation procedure kit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1075 FDA UDI
888.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

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

Dimensions & Sizes

Size
Outer Diameter — 7.5 Millimeter FDA UDI

Category: Internal spinal fixation procedure kit, single-use

K2M Fenestrated Tap System by K2m, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
K2m, Inc.

Sources (1)

  • FDA UDI 1970bb84-4735-4247-8edc-7186f90c13c8 36 fields · synced May 30, 2026