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Actera

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name
ACTERA FDA UDI
Generic Name
Coated femoral stem prosthesis, one-piece FDA UDI
Device Name
HIPRX STEM SIZE 10 RIGHT OR LEFT FDA UDI
Model / Reference
HES-034-0010-01 FDA UDI
Description
HIPRX STEM SIZE 10 RIGHT OR LEFT FDA UDI

Identifiers

Catalog Number
HES-034-0010 FDA UDI
Primary DI / UDI-DI
M572HES0340010011 FDA UDI
510(k) Number
K231178 FDA UDI
FDA Product Code
MEH FDA UDI
OQG FDA UDI
GMDN Term
Coated femoral stem prosthesis, one-piece 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coated femoral stem prosthesis, one-piece

Actera by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated femoral stem prosthesis, one-piece.

Cleared under the same submission

K231178 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Conformis, Inc.

Sources (1)

  • FDA UDI 296501ba-3626-4cf0-b623-9da65bd22a4a 37 fields · synced May 30, 2026