PANGEA 542153

GUDID 07613327625127

Handle Extra Articular Tibia, MIS

Stryker Trauma SA

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 07613327625127
• NIH Device Record Key: 21ed59f4-ec3a-4a41-9f15-01dfc9875d9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PANGEA
• Version Model Number: 542153
• Catalog Number: 542153
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 204 Millimeter
• Length: 204 Millimeter
• Length: 204 Millimeter
• Length: 204 Millimeter
• Length: 204 Millimeter
• Length: 204 Millimeter
• Length: 204 Millimeter
• Length: 204 Millimeter
• Length: 204 Millimeter
• Length: 204 Millimeter
• Length: 204 Millimeter
• Length: 204 Millimeter
• Length: 204 Millimeter
• Length: 204 Millimeter
• Length: 204 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327625127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242445

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07613327625127]

Moist Heat or Steam Sterilization

[07613327625127]

Moist Heat or Steam Sterilization

[07613327625127]

Moist Heat or Steam Sterilization

[07613327625127]

Moist Heat or Steam Sterilization

[07613327625127]

Moist Heat or Steam Sterilization

[07613327625127]

Moist Heat or Steam Sterilization

[07613327625127]

Moist Heat or Steam Sterilization

[07613327625127]

Moist Heat or Steam Sterilization

[07613327625127]

Moist Heat or Steam Sterilization

[07613327625127]

Moist Heat or Steam Sterilization

[07613327625127]

Moist Heat or Steam Sterilization

[07613327625127]

Moist Heat or Steam Sterilization

[07613327625127]

Moist Heat or Steam Sterilization

[07613327625127]

Moist Heat or Steam Sterilization

[07613327625127]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-05
• Device Publish Date: 2024-11-27

On-Brand Devices [PANGEA]

• 07613327541748: Tap, Cancellous
• 07613327541731: Tap, Cortical
• 07613327541489: Tray for Proximal Femur Targeters
• 07613327541151: Tray for Interprosthetic Femur Targeters
• 07613327539677: Frame Fixator, MIS
• 07613327539660: Handle Locking Rod, MIS
• 07613327539653: Handle Thumb Wheel, MIS
• 07613327539646: Screwdriver Bit, MIS
• 07613327539622: Depth Gauge, MIS
• 07613327539615: Tissue Protection Sleeve, MIS
• 07613327539608: K-Wire Sleeve, MIS
• 07613327539592: Drill Bit, MIS
• 07613327539585: Drill Bit, MIS
• 07613327539578: Drill Bit, MIS
• 07613327539561: Drill Bit, MIS
• 07613327539554: Paddle Trocar, MIS
• 07613327539547: Drill Sleeve, MIS
• 07613327539530: Handle Body, MIS
• 07613327539523: Targeter Proximal Femur
• 07613327539516: Targeter Interprosthetic Femur
• 07613327539509: Targeter Interprosthetic Femur
• 07613327539493: Targeter Distal Femur
• 07613327539486: Targeter Distal Femur
• 07613327539479: Targeter Proximal Femur
• 07613327539462: Targeter Distal Femur
• 07613327539455: Targeter Interprosthetic Femur
• 07613327505658: Tap, Locking
• 07613327505641: Tap, Locking
• 07613327505634: Soft Tissue Elevator, long
• 07613327505627: Variable Angle Drill Guide
• 07613327505337: Torque Limiter
• 07613327505320: Cable Plug
• 07613327505306: Drill Sleeve Insert
• 07613327471731: Interprosthetic Femur Plate, Right
• 07613327471724: Locking Screw, Flat Tip
• 07613327471700: Locking Screw, Flat Tip
• 07613327471694: Locking Screw, Flat Tip
• 07613327471670: Proximal Femur Plate Trial Tag
• 07613327471663: Interprosthetic Femur Plate Trial Tag
• 07613327471656: Locking Screw, Flat Tip
• 07613327471649: Locking Screw, Flat Tip
• 07613327471632: Interprosthetic Femur Plate, Left
• 07613327471625: Locking Screw, Flat Tip
• 07613327471618: Locking Screw, Flat Tip
• 07613327471588: Locking Screw, Flat Tip
• 07613327471571: Locking Screw, Flat Tip
• 07613327471564: Distal Femur Plate Trial Tag
• 07613327471557: Locking Screw, Flat Tip
• 07613327471540: Locking Screw, Flat Tip
• 07613327471526: Locking Screw, Flat Tip