Pangea

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: PANGEA FDA UDI
Generic Name: Orthopaedic implant aiming arm FDA UDI
Device Name: Targeter Proximal Femur FDA UDI
Model / Reference: 706436 FDA UDI
Description: Targeter Proximal Femur FDA UDI

Identifiers

Catalog Number: 706436 FDA UDI
Primary DI / UDI-DI: 07613327539479 FDA UDI
510(k) Number: K222381 FDA UDI
FDA Product Code: HWC FDA UDI
HRS FDA UDI
GMDN Term: Orthopaedic implant aiming arm 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

FDA UDI

Implantable

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

Category: Orthopaedic implant aiming arm

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

Similar devices

Also classified as Orthopaedic implant aiming arm.

ANTEGRADE TARGETING MODULE FEMORAL NAIL SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
TARGETING ARM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
Dyna Locking Trochanteric Nail — CG MedTech Co., Ltd. · Class I
ANTEGRADE FEMORAL NAIL DRIVER — Biomet Orthopedics, Inc. · Class I
Jig — I.T.S. GmbH · Class I
ACUFEX — Smith & Nephew, Inc. · Class I
ENDO - KNEE — Smith & Nephew, Inc. · Class I
Proximal Humeral Fracture Plate System — Smith & Nephew, Inc. · Class I

Cleared under the same submission

K222381 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Stryker Corp.

Sources (1)

FDA UDI 8c0664e2-4008-4a7f-87e2-7ade1fdd1821 35 fields · synced Jun 8, 2026