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Mako

FDA UDI

Class II (US FDA UDI)

by MAKO Surgical Corp.

Identity

Trade Name
Mako FDA UDI
Generic Name
Robotic surgical navigation system application software FDA UDI
Model / Reference
213951 FDA UDI

Identifiers

Catalog Number
213951 FDA UDI
Primary DI / UDI-DI
07613327395341 FDA UDI
510(k) Number
K191998 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Robotic surgical navigation system application software 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Robotic surgical navigation system application software

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

Similar devices

Also classified as Robotic surgical navigation system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MAKO Surgical Corp.

Sources (1)

  • FDA UDI a0926ba1-22c4-41fe-8a09-6ea190fc81ef 34 fields · synced Jun 9, 2026