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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
Trials, 32x24, 12°, 12mm FDA UDI
Model / Reference
1030-32241212 FDA UDI
Description
Trials, 32x24, 12°, 12mm FDA UDI

Identifiers

Primary DI / UDI-DI
00843210171616 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

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

No

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: Spinal implant trial

Indy, a reusable spinal implant trial, is used to validate the proper size of permanent implants, determine their position, and verify dimensions. This device is made from metal or plastic and can be sterilized using Moist Heat or Steam Sterilization.

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K182406 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Altus Spine

Sources (1)

  • FDA UDI 329c648d-344d-44bf-a7e2-c192687ba120 35 fields · synced Jun 29, 2026