8.0mm Nut

FDA UDI

Class II (US FDA UDI)

by OsteoCentric Technologies, Inc

Identity

Trade Name: 8.0mm Nut FDA UDI
Generic Name: Implantable bone nut FDA UDI
Device Name: 8.0mm Nut FDA UDI
Model / Reference: 380-7000 FDA UDI
Description: 8.0mm Nut FDA UDI

Identifiers

Catalog Number: 380-7000 FDA UDI
Primary DI / UDI-DI: 00810074306423 FDA UDI
510(k) Number: K242691 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Implantable bone nut FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Implantable bone nut

8.0mm Nut by OsteoCentric Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable bone nut.

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T2 — Stryker Corp. · Class I
Nut — I.T.S. GmbH · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II
Arthrex® — Arthrex, Inc. · Class I
M/DN® — Zimmer, Inc. · Class II

Cleared under the same submission

K242691 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: OsteoCentric Technologies, Inc

Sources (1)

FDA UDI aa7c5617-8572-4fc0-ae4a-605cc2976a5e 36 fields · synced May 30, 2026