Instrument

FDA UDI

Class II (US FDA UDI)

by MAKO Surgical Corp.

Identity

Trade Name: INSTRUMENT FDA UDI
Generic Name: Stereotactic surgery system probe, reusable FDA UDI
Device Name: Spine Pedicle Registration Tool FDA UDI
Model / Reference: 700002150095 FDA UDI
Description: Spine Pedicle Registration Tool FDA UDI

Identifiers

Catalog Number: 700002150095 FDA UDI
Primary DI / UDI-DI: 07613327625875 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Stereotactic surgery system probe, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 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: Stereotactic surgery system probe, reusable

Instrument by MAKO Surgical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: MAKO Surgical Corp.

Sources (1)

FDA UDI 0b57ea26-8467-4bc0-b9b8-dbeddc591a47 34 fields · synced Jun 9, 2026