Variax

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: VARIAX FDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Model / Reference: 625090S FDA UDI

Identifiers

Catalog Number: 625090S FDA UDI
Primary DI / UDI-DI: 07613327344592 FDA UDI
510(k) Number: K212581 FDA UDI
FDA Product Code: HRS FDA UDI
GMDN Term: Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 47.0 Millimeter FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable

Variax by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic fixation plate, non-bioabsorbable.

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Cleared under the same submission

K212581 also covers:

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: Stryker Corp.

Sources (1)

FDA UDI a4c24a52-4e3b-4c11-aa26-2834e80a7261 35 fields · synced May 30, 2026