Indy

FDA UDI

Class II (US FDA UDI)

by Altus Spine

Identity

Trade Name: Indy FDA UDI
Generic Name: Orthopaedic surgical distractor, internal FDA UDI
Device Name: 13mm H, 12° Distractor FDA UDI
Model / Reference: 1020-1213 FDA UDI
Description: 13mm H, 12° Distractor FDA UDI

Identifiers

Primary DI / UDI-DI: 00843210143552 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Orthopaedic surgical distractor, internal 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

Dimensions & Sizes

Size: Height — 13 Millimeter FDA UDI

Category: Orthopaedic surgical distractor, internal

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

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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 470af3eb-8520-40fb-9cbd-375a3e89c827 35 fields · synced Jun 1, 2026