Novation Element

FDA UDI

Class I (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Novation Element FDA UDI
Generic Name: Femoral stem prosthesis trial FDA UDI
Device Name: NV ELEM RO NT S/O SZ 13 NECK TRIAL FDA UDI
Model / Reference: 165-11-13 FDA UDI
Description: NV ELEM RO NT S/O SZ 13 NECK TRIAL FDA UDI

Identifiers

Catalog Number: 165-11-13 FDA UDI
Primary DI / UDI-DI: 10885862204103 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Femoral stem prosthesis trial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 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

Yes

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: Femoral stem prosthesis trial

Novation Element by Exactech, Inc. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Exactech, Inc.

Sources (1)

FDA UDI 8766654f-a8db-487b-80a1-7791a3065d8f 35 fields · synced Jun 6, 2026