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.

07613327522006 - Mako	2026-01-22 MICS 3 Handpiece
07613327595505 - Mako Glenoid Retractor	2026-01-16
07613327595741 - Black Probe	2026-01-16
07613327523874 - Mako	2025-02-14 MICS Sagittal Saw Attachment , Angled
07613327627220 - Mako	2024-11-26 MAKO SHOULDER ROUTER
07613327627565 - Mako	2024-11-26 MICS SAGITTAL BLADE, STANDARD
07613327627572 - Mako	2024-11-26 Blade-Narrow
07613327626971 - Mako	2024-11-25 Mako Shoulder Array Kit

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