700000380980

GUDID 07613327468298

Crest Pin Clamp

MAKO SURGICAL CORP.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 07613327468298
• NIH Device Record Key: af6aceda-9bad-4ac8-b2c0-948ed2f074a0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 700000380980
• Catalog Number: 700000380980
• Company DUNS: 175239677
• Company Name: MAKO SURGICAL CORP.
• 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

Customer Support Contacts

• Phone: +1(954)628-0802
• Email: MakoCustomerService@stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327468298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193128

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

[07613327468298]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-09
• Device Publish Date: 2020-02-28

Devices Manufactured by MAKO SURGICAL CORP.

• 07613327595482 - Scapular Clamp: 2026-02-09
• 07613327595567 - Robotic Arm Array Mount: 2026-02-09
• 07613327595772 - Shoulder irrigation Clip, Sterile: 2026-02-09
• 07613327623277 - Lower Tray, Mako Shoulder Tray: 2026-02-09
• 07613327623284 - Double Tier Tray Outer Shell: 2026-02-09
• 07613327625530 - MAKO Knee Tray Bottom Insert: 2026-02-09
• 07613327522006 - Mako: 2026-01-22 MICS 3 Handpiece
• 07613327595505 - Mako Glenoid Retractor: 2026-01-16