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Ingenix

FDA UDI

Class II (US FDA UDI)

by Ingenium Spine

Identity

Trade Name
INGENIX FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Polyax screw 4.75x40mm for 5.5 rod FDA UDI
Model / Reference
55014740 FDA UDI
Description
Polyax screw 4.75x40mm for 5.5 rod FDA UDI

Identifiers

Primary DI / UDI-DI
00843672100025 FDA UDI
510(k) Number
K173126 FDA UDI
FDA Product Code
KWP FDA UDI
NKB FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable 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

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

Category: Spinal bone screw, non-bioabsorbableBone-screw internal spinal fixation system, non-sterile

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

Similar devices

Also classified as Bone-screw internal spinal fixation system, non-sterile.

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 ddd18ca9-d43e-49ca-867d-c5936b9d715c 34 fields · synced Jun 1, 2026