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Humelock Cemented Shoulder Prosthesis

FDA UDI

Class II (US FDA UDI)

by Fx Solutions

Identity

Trade Name
Humelock Cemented Shoulder Prosthesis FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
TRIAL OFFSET HEAD 48x19 FDA UDI
Model / Reference
926-1018 FDA UDI
Description
TRIAL OFFSET HEAD 48x19 FDA UDI

Identifiers

Catalog Number
926-1018 FDA UDI
Primary DI / UDI-DI
03701037306994 FDA UDI
510(k) Number
K111097 FDA UDI
FDA Product Code
HSD FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3690 FDA UDI
Commercial Distribution
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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 48 Millimeter FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Humelock Cemented Shoulder Prosthesis by Fx Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.

Cleared under the same submission

K111097 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fx Solutions

Sources (1)

  • FDA UDI 84f1a7a4-c098-47d0-a243-d8b4c616c9b5 37 fields · synced Jun 6, 2026