← Back to catalogue

Mako

FDA UDI

Class II (US FDA UDI)

by MAKO Surgical Corp.

Identity

Trade Name
Mako FDA UDI
Generic Name
Surgical saw blade, oscillating, single-use FDA UDI
Device Name
Blade-Narrow FDA UDI
Model / Reference
1020-200-075 FDA UDI
Description
Blade-Narrow FDA UDI

Identifiers

Catalog Number
1020-200-075 FDA UDI
Primary DI / UDI-DI
07613327627572 FDA UDI
510(k) Number
K193128 FDA UDI
K220459 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Surgical saw blade, oscillating, single-use 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical saw blade, oscillating, single-use

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

Similar devices

Also classified as Surgical saw blade, oscillating, single-use.

Cleared under the same submission

K193128 also covers:

K220459 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
MAKO Surgical Corp.

Sources (1)

  • FDA UDI 54fda544-18e2-414f-9d04-e7e1219fb972 35 fields · synced Jun 9, 2026