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Avenger

FDA UDI

Class I (US FDA UDI)

by In2Bones, USA

Identity

Trade Name
Avenger FDA UDI
Generic Name
Orthopaedic bur, reusable FDA UDI
Device Name
Reamer Assembly, Size 5.5mm, Reusable, NS FDA UDI
Model / Reference
M07 N0021 FDA UDI
Description
Reamer Assembly, Size 5.5mm, Reusable, NS FDA UDI

Identifiers

Catalog Number
M07 N0021 FDA UDI
Primary DI / UDI-DI
00810021862552 FDA UDI
510(k) Number
K192754 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 Conditional FDA UDI

Category: Orthopaedic bur, reusable

Avenger 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

K192754 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 806694ef-9c15-4eb5-b286-50f4fc9671c5 36 fields · synced May 30, 2026