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Indy Standalone

FDA UDI

Class I (US FDA UDI)

by Altus Spine

Identity

Trade Name
Indy Standalone FDA UDI
Generic Name
Surgical screwdriver, reusable FDA UDI
Device Name
U-Joint T15 Self-Retaining Screwdriver, Short FDA UDI
Model / Reference
1030-0301A FDA UDI
Description
U-Joint T15 Self-Retaining Screwdriver, Short FDA UDI

Identifiers

Primary DI / UDI-DI
00843210172941 FDA UDI
510(k) Number
K211837 FDA UDI
FDA Product Code
HXX FDA UDI
GMDN Term
Surgical screwdriver, reusable 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

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: Surgical screwdriver, reusable

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

Similar devices

Also classified as Surgical screwdriver, reusable.

Cleared under the same submission

K211837 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 1cac3c28-556f-40b8-b935-9dcd82f2de45 35 fields · synced May 31, 2026