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Anato

FDA UDI

Class II (US FDA UDI)

by MAKO Surgical Corp.

Identity

Trade Name
ANATO FDA UDI
Generic Name
Femoral stem prosthesis trial FDA UDI
Device Name
NEUTRAL TRIAL NECK, ANTEVERTED FDA UDI
Model / Reference
209873 FDA UDI
Description
NEUTRAL TRIAL NECK, ANTEVERTED FDA UDI

Identifiers

Catalog Number
209873 FDA UDI
Primary DI / UDI-DI
00848486030322 FDA UDI
510(k) Number
K141989 FDA UDI
K170593 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Femoral stem prosthesis trial 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Femoral stem prosthesis trial

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

Similar devices

Also classified as Femoral stem prosthesis trial.

Cleared under the same submission

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 14bfd38d-b70f-4862-b871-202f86453c83 35 fields · synced Jun 9, 2026