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Encore Hip Stem

FDA UDI

Class II (US FDA UDI)

by Signature Orthopaedics Pty Ltd

Identity

Trade Name
Encore Hip Stem FDA UDI
Generic Name
Coated hip femur prosthesis, modular FDA UDI
Model / Reference
111-45-1111 FDA UDI

Identifiers

Primary DI / UDI-DI
09348215082840 FDA UDI
510(k) Number
K211505 FDA UDI
FDA Product Code
MEH FDA UDI
LZO FDA UDI
GMDN Term
Coated hip femur prosthesis, modular FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3353 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Encore Hip Stem by Signature Orthopaedics Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K211505 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Signature Orthopaedics Pty Ltd

Sources (1)

  • FDA UDI 35264d2c-84f8-4efd-9545-7eff3c66e79c 34 fields · synced May 31, 2026