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TiN Coated Glenosphere

FDA UDI

Class II (US FDA UDI)

by Fx Solutions

Identity

Trade Name
TiN Coated Glenosphere FDA UDI
Generic Name
Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
Device Name
HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10° TILT Ø36mm FDA UDI
Model / Reference
115-3613 FDA UDI
Description
HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10° TILT Ø36mm FDA UDI

Identifiers

Catalog Number
115-3613 FDA UDI
Primary DI / UDI-DI
03701037300817 FDA UDI
510(k) Number
K191146 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

Category: Shoulder glenoid fossa prosthesis, prefabricated

TiN Coated Glenosphere 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

K191146 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 989bb314-278d-4336-bb6d-49ca7eff58ba 36 fields · synced Jun 8, 2026