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Humelock Reversed System

FDA UDI

Class II (US FDA UDI)

by Fx Solutions

Identity

Trade Name
Humelock Reversed System FDA UDI
Generic Name
Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
Device Name
HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø32mm FDA UDI
Model / Reference
105-3211 FDA UDI
Description
HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø32mm FDA UDI

Identifiers

Catalog Number
105-3211 FDA UDI
Primary DI / UDI-DI
03701037309483 FDA UDI
510(k) Number
K192206 FDA UDI
FDA Product Code
PHX FDA UDI
GMDN Term
Shoulder glenoid fossa prosthesis, prefabricated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 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

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 — 32 Millimeter FDA UDI

Category: Shoulder glenoid fossa prosthesis, prefabricated

Humelock Reversed System by Fx Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Shoulder glenoid fossa prosthesis, prefabricated.

Cleared under the same submission

K192206 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 8a1daf58-5b19-4767-b2e8-b09bdbf9ceb4 37 fields · synced Jun 1, 2026