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Humelock Ii Cemented Shoulder System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K123814

by Fx Solutions

Identity

Trade Name
Humelock II Cemented Shoulder System FDA UDI
Generic Name
Uncoated shoulder humeral stem prosthesis FDA UDI
Device Name
HUMELOCK II STEM TA6V SIZE 09 CEMENTED FDA UDI
Model / Reference
311-0309 FDA UDI
Description
HUMELOCK II STEM TA6V SIZE 09 CEMENTED FDA UDI

Identifiers

Catalog Number
311-0309 FDA UDI
Primary DI / UDI-DI
03701037301135 FDA UDI
510(k) Number
K123814 FDA 510(k)FDA UDI
FDA Product Code
KWT FDA 510(k)
HSD FDA UDI
GMDN Term
Uncoated shoulder humeral stem prosthesis FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3650 FDA 510(k)
Regulation Number
888.3650 FDA 510(k)
888.3690 FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

No

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

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 9 Millimeter FDA UDI

Humelock Ii Cemented Shoulder System by Fx Solutions — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fx Solutions

Sources (2)

  • FDA 510(k) K123814 24 fields · synced Jun 18, 2026
  • FDA UDI d45fc85f-52f1-4b6f-be29-24d37086c3d3 38 fields · synced May 27, 2026