Anatomic

FDA UDI

Class II (US FDA UDI)

by Amplitude

Identity

Trade Name: ANATOMIC FDA UDI
Generic Name: Tibial insert FDA UDI
Device Name: ANATOMIC® Posterior Stabilized Fixed Bearing Insert Size 8 Thickness 20 mm FDA UDI
Model / Reference: 1-0209785 FDA UDI
Description: ANATOMIC® Posterior Stabilized Fixed Bearing Insert Size 8 Thickness 20 mm FDA UDI

Identifiers

Catalog Number: 1-0209785 FDA UDI
Primary DI / UDI-DI: 03701089500715 FDA UDI
510(k) Number: K161414 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Tibial insert FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Tibial insert

Anatomic by Amplitude — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Scorpio — Howmedica Osteonics Corp. · Class II
TriVerse Meniscal Insert PS+ — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
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World Knee System — SIGNATURE ORTHOPAEDICS PTY LTD · Class II

Cleared under the same submission

K161414 also covers:

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: Amplitude

Sources (1)

FDA UDI 902429d0-a3e7-427c-8f5d-adb3a50568bc 36 fields · synced May 30, 2026