Indy

FDA UDI

Class II (US FDA UDI)

by Altus Spine

Identity

Trade Name: Indy FDA UDI
Generic Name: Spinal implant trial FDA UDI
Device Name: 32mm x 24mm, 16°, 19mm PEEK Spacer FDA UDI
Model / Reference: FA32241619 FA32241619T FDA UDI
Description: 32mm x 24mm, 16°, 19mm PEEK Spacer FDA UDI

Identifiers

Primary DI / UDI-DI: 00843210137636 FDA UDI
510(k) Number: K182406 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Spinal implant trial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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: Spinal implant trial

Indy by Altus Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MLX — Nuvasive, Inc. · Class I
IdentiTi — ALPHATEC SPINE, INC. · Class II
ROI-A — Ldr Spine USA · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Altus Spine

Sources (1)

FDA UDI cf8e9fd1-5b7c-4a31-80ae-6e1cbacf6151 35 fields · synced May 31, 2026