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Indy

FDA UDI

Class I (US FDA UDI)

by Altus Spine

Identity

Trade Name
Indy FDA UDI
Generic Name
Surgical instrument handle, torque-limiting FDA UDI
Device Name
Torque-Limiting Handle, Small Hudson Connection FDA UDI
Model / Reference
1030-0901 FDA UDI
Description
Torque-Limiting Handle, Small Hudson Connection FDA UDI

Identifiers

Primary DI / UDI-DI
00843210173085 FDA UDI
510(k) Number
K182406 FDA UDI
FDA Product Code
HWJ FDA UDI
GMDN Term
Surgical instrument handle, torque-limiting 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 instrument handle, torque-limiting

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

Similar devices

Also classified as Surgical instrument handle, torque-limiting.

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 90b37f63-bd48-4136-ac00-3665e0c017ed 35 fields · synced Jun 1, 2026