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In2Bones

FDA UDI

Class I (US FDA UDI)

by In2Bones, USA

Identity

Trade Name
In2Bones FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Sterile Disposable Instruments for Ø2.4 and Ø 2.7 mm Plate Screws FDA UDI
Model / Reference
P06 S0001 FDA UDI
Description
Sterile Disposable Instruments for Ø2.4 and Ø 2.7 mm Plate Screws FDA UDI

Identifiers

Catalog Number
P06 S0001 FDA UDI
Primary DI / UDI-DI
00817906024210 FDA UDI
510(k) Number
K170518 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, single-use

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

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.

Cleared under the same submission

K170518 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
In2Bones, USA

Sources (1)

  • FDA UDI 356e4c2d-f5c1-4736-8048-7370df33b961 36 fields · synced May 30, 2026