N-Force 4.0 Fixation System

FDA UDI

Class I (US FDA UDI)

by Innovision, Inc

Identity

Trade Name: N-Force 4.0 Fixation System FDA UDI
Generic Name: Bone access cannula FDA UDI
Device Name: N-Force 4.0 Fixation System Sheath & Sheath Adapter Assembly FDA UDI
Model / Reference: IN048-FS FDA UDI
Description: N-Force 4.0 Fixation System Sheath & Sheath Adapter Assembly FDA UDI

Identifiers

Catalog Number: IN048-FS FDA UDI
Primary DI / UDI-DI: 00815612020229 FDA UDI
510(k) Number: K132244 FDA UDI
K151146 FDA UDI
FDA Product Code: GEA FDA UDI
GMDN Term: Bone access cannula FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Bone access cannula

N-Force 4.0 Fixation System by Innovision, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Innovision, Inc

Sources (1)

FDA UDI ad7b0e7b-46a3-47ab-aa31-8dced8ea528b 36 fields · synced Jun 8, 2026