← Back to catalogue

Arthrex®

FDA UDI

Class II (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name
Arthrex® FDA UDI
Generic Name
Uncoated knee tibia/insert prosthesis FDA UDI
Device Name
IBAL TKA,BEARING IMP,CR,SZ 4,11MM FDA UDI
Model / Reference
AR-513-RE11 FDA UDI
Description
IBAL TKA,BEARING IMP,CR,SZ 4,11MM FDA UDI

Identifiers

Catalog Number
AR-513-RE11 FDA UDI
Primary DI / UDI-DI
00888867108165 FDA UDI
FDA Product Code
KRR FDA UDI
MBH FDA UDI
HSX FDA UDI
GMDN Term
Uncoated knee tibia/insert prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3540 FDA UDI
888.3565 FDA UDI
888.3520 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
MRI Safety
MR Conditional FDA UDI

Category: Uncoated knee tibia/insert prosthesis

Arthrex® by Arthrex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated knee tibia/insert prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Arthrex, Inc.

Sources (1)

  • FDA UDI 06f2bf25-b336-47a8-b4e0-c061aa0ab1bf 35 fields · synced May 29, 2026