Pangea

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: PANGEA FDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name: 3.5 Curved Narrow Plate FDA UDI
Model / Reference: 541243 FDA UDI
Description: 3.5 Curved Narrow Plate FDA UDI

Identifiers

Catalog Number: 541243 FDA UDI
Primary DI / UDI-DI: 07613327608229 FDA UDI
510(k) Number: K231257 FDA UDI
FDA Product Code: HWC FDA UDI
HRS FDA UDI
GMDN Term: Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 206.0 Millimeter FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable

Pangea 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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osteo-WEDGE2 12 Degree Angulated Bone Plate Implant, Large — Gramedica · Class II

Cleared under the same submission

K231257 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 5019865a-889b-48b7-bca4-031dc316b6a0 36 fields · synced May 31, 2026