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Ingenix

FDA UDI

Class II (US FDA UDI)

by Ingenium Spine

Identity

Trade Name
INGENIX FDA UDI
Generic Name
Bone tap, reusable FDA UDI
Device Name
Tap for 7.0mm Screw FDA UDI
Model / Reference
56010020 FDA UDI
Description
Tap for 7.0mm Screw FDA UDI

Identifiers

Primary DI / UDI-DI
00843672101534 FDA UDI
510(k) Number
K173126 FDA UDI
FDA Product Code
KWP FDA UDI
NKB FDA UDI
GMDN Term
Bone tap, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3050 FDA UDI
888.3070 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

Category: Bone tap, reusable

Ingenix by Ingenium Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone tap, reusable.

Cleared under the same submission

K173126 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ingenium Spine

Sources (1)

  • FDA UDI 4253435a-de9b-4bd5-b527-aa6e5ba86d55 34 fields · synced Jun 7, 2026