In2Bones

FDA UDI

Class I (US FDA UDI)

by In2Bones, USA

Identity

Trade Name: In2Bones FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: T20 DRIVER, AO, SINGLE-USE, NON-STERILE FDA UDI
Model / Reference: P02 N0151 FDA UDI
Description: T20 DRIVER, AO, SINGLE-USE, NON-STERILE FDA UDI

Identifiers

Catalog Number: P02 N0151 FDA UDI
Primary DI / UDI-DI: 00810021865195 FDA UDI
510(k) Number: K213069 FDA UDI
FDA Product Code: HWR FDA UDI
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Surgical screwdriver, reusable

In2Bones by In2Bones, USA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical screwdriver, reusable.

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USS — Synthes · Class I
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I

Cleared under the same submission

K213069 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 I	Pending data

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Manufacturer

Manufacturer: In2Bones, USA

Sources (1)

FDA UDI aa562dde-c6e4-44bd-bb1e-d5c24ad507cc 36 fields · synced Jun 8, 2026