ART End Cap

FDA UDI

Class II (US FDA UDI)

by Orthopedic Designs North America, Inc.

Identity

Trade Name: ART End Cap FDA UDI
Generic Name: Bone nail end-cap FDA UDI
Device Name: ART End Cap Ø13mm x 10mm (+10) FDA UDI
Model / Reference: ART13C10 FDA UDI
Description: ART End Cap Ø13mm x 10mm (+10) FDA UDI

Identifiers

Catalog Number: ART-13-C10 FDA UDI
Primary DI / UDI-DI: B058ART13C101 FDA UDI
510(k) Number: K152295 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Bone nail end-cap FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 13 Millimeter FDA UDI
Length — 10 Millimeter FDA UDI

Category: Bone nail end-cap

ART End Cap by Orthopedic Designs North America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K152295 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Orthopedic Designs North America, Inc.

Sources (1)

FDA UDI d5c535c8-7a73-43a3-a93e-2c420e2053be 37 fields · synced May 30, 2026