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In2Bones

FDA UDI

Class I (US FDA UDI)

by In2Bones, USA

Identity

Trade Name
In2Bones FDA UDI
Generic Name
Orthopaedic bur, reusable FDA UDI
Device Name
Ø4.5 MM X 120 MM DRILL, SINGLE-USE, NON-STERILE FDA UDI
Model / Reference
P02 N0161 FDA UDI
Description
Ø4.5 MM X 120 MM DRILL, SINGLE-USE, NON-STERILE FDA UDI

Identifiers

Catalog Number
P02 N0161 FDA UDI
Primary DI / UDI-DI
00810021865201 FDA UDI
510(k) Number
K213069 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic bur, 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Orthopaedic bur, reusable

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

Similar devices

Also classified as Orthopaedic bur, reusable.

Cleared under the same submission

K213069 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 ba18b871-ee67-4987-9b96-84d4f5b68cae 36 fields · synced Jun 1, 2026