FX V 135 stem

FDA UDI

Class II (US FDA UDI)

by Fx Solutions

Identity

Trade Name: FX V 135 stem FDA UDI
Generic Name: Coated shoulder humeral stem prosthesis FDA UDI
Device Name: FX V135 LONG STEM TA6V CEMENTLESS Ø32/09 LG180mm Ti/HA FDA UDI
Model / Reference: 318-1811 FDA UDI
Description: FX V135 LONG STEM TA6V CEMENTLESS Ø32/09 LG180mm Ti/HA FDA UDI

Identifiers

Catalog Number: 318-1811 FDA UDI
Primary DI / UDI-DI: 03701037318430 FDA UDI
510(k) Number: K223801 FDA UDI
FDA Product Code: PHX FDA UDI
KWT FDA UDI
HSD FDA UDI
GMDN Term: Coated shoulder humeral stem prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
888.3650 FDA UDI
888.3690 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Coated shoulder humeral stem prosthesis

FX V 135 stem by Fx Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated shoulder humeral stem prosthesis.

OsseoFit™ Stemless Shoulder — Zimmer, Inc. · Class II
TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
Tornier HRS — TORNIER, INC. · Class II
Comprehensive® Shoulder System — Biomet Orthopedics, Inc. · Class II
Trabecular Metal® — Zimmer, Inc. · Class II
Comprehensive SRS — Biomet Orthopedics, Inc. · Class II
INHANCE — DEPUY (IRELAND) · Class II
Aequalis™ PerFORM+ — TORNIER, INC. · Class II

Cleared under the same submission

K223801 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Fx Solutions

Sources (1)

FDA UDI 52685554-4440-4155-9d30-49b01b975eb0 35 fields · synced Jun 8, 2026