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Encore Stem Trial Neck

FDA UDI

Class I (US FDA UDI)

by Signature Orthopaedics Pty Ltd

Identity

Trade Name
Encore Stem Trial Neck FDA UDI
Generic Name
Surgical implant template, reusable FDA UDI
Model / Reference
111-45-0717 FDA UDI

Identifiers

Primary DI / UDI-DI
09348215083236 FDA UDI
510(k) Number
K211505 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Surgical implant template, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Encore Stem Trial Neck by Signature Orthopaedics Pty Ltd — Class I — 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 aa611b05-086f-42ea-8324-1079b835931c 34 fields · synced May 31, 2026