Brickyard

FDA UDI

Class I (US FDA UDI)

by Altus Spine

Identity

Trade Name: Brickyard FDA UDI
Generic Name: Orthopaedic surgical distractor, internal FDA UDI
Device Name: Angled Distractor Tip, 12°, 20mm FDA UDI
Model / Reference: 1030-1220 FDA UDI
Description: Angled Distractor Tip, 12°, 20mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00843210181554 FDA UDI
510(k) Number: K182406 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic surgical distractor, internal 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

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic surgical distractor, internal

Brickyard by Altus Spine — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K182406 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 I	Pending data

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Manufacturer

Manufacturer: Altus Spine

Sources (1)

FDA UDI 06eefc36-f28b-4b9a-b3bd-1216cfb6c24f 35 fields · synced May 31, 2026