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AR Specialty Femoral

FDA UDI

Class I (US FDA UDI)

by b-ONE Ortho Corp.

Identity

Trade Name
AR Specialty Femoral FDA UDI
Generic Name
Orthopaedic implant/instrument assembling device FDA UDI
Device Name
Femoral Spacer Block - One Side -25mm FDA UDI
Model / Reference
8829P00027 FDA UDI
Description
Femoral Spacer Block - One Side -25mm FDA UDI

Identifiers

Catalog Number
8829P00027 FDA UDI
Primary DI / UDI-DI
00843575112446 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic implant/instrument assembling device 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

Yes

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

Category: Orthopaedic implant/instrument assembling device

AR Specialty Femoral by b-ONE Ortho Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant/instrument assembling device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
b-ONE Ortho Corp.

Sources (1)

  • FDA UDI d733c2f3-781d-4f7e-aec5-56fee2a1bccf 34 fields · synced May 30, 2026