Actera Hip Trial Neck, Reusable Size 10-11-12 High Offset

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name: ACTERA HIP TRIAL NECK, REUSABLE SIZE 10-11-12 HIGH OFFSET FDA UDI
Generic Name: Femoral stem prosthesis trial FDA UDI
Device Name: ACTERA HIP TRIAL NECK, REUSABLE SIZE 10-11-12 HIGH OFFSET FDA UDI
Model / Reference: 1080-695 FDA UDI
Description: ACTERA HIP TRIAL NECK, REUSABLE SIZE 10-11-12 HIGH OFFSET FDA UDI

Identifiers

Catalog Number: 1080-695 FDA UDI
Primary DI / UDI-DI: 00810933031633 FDA UDI
510(k) Number: K231178 FDA UDI
FDA Product Code: MEH FDA UDI
OQG FDA UDI
GMDN Term: Femoral stem prosthesis trial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3358 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

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

Actera Hip Trial Neck, Reusable Size 10-11-12 High Offset by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K231178 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: Conformis, Inc.

Sources (1)

FDA UDI 559799c5-5836-48c8-bbd6-fd7bfe489d0f 36 fields · synced May 30, 2026