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Star™

FDA UDI

Class III (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
STAR™ FDA UDI
Generic Name
Coated ankle tibia prosthesis FDA UDI
Device Name
Tibial Component, Single Coated/US Version, SMALL FDA UDI
Model / Reference
400-261 FDA UDI
Description
Tibial Component, Single Coated/US Version, SMALL FDA UDI

Identifiers

Primary DI / UDI-DI
00886385016528 FDA UDI
FDA Product Code
NTG FDA UDI
GMDN Term
Coated ankle tibia prosthesis FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 30 Millimeter FDA UDI
Width — 32 Millimeter FDA UDI

Category: Coated ankle tibia prosthesis

Star™ by Stryker Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated ankle tibia prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI 91c63e9d-e0ce-4c3f-b7bb-5f11c9e02770 35 fields · synced May 30, 2026