FX V135 Shoulder Prosthesis

FDA UDI

Class II (US FDA UDI)

by Fx Solutions

Identity

Trade Name: FX V135 Shoulder Prosthesis FDA UDI
Generic Name: Stem-fixed metallic humeral head prosthesis FDA UDI
Device Name: OFFSET HEAD 48x17 FDA UDI
Model / Reference: 206-4832 FDA UDI
Description: OFFSET HEAD 48x17 FDA UDI

Identifiers

Primary DI / UDI-DI: 03701037317129 FDA UDI
510(k) Number: K213117 FDA UDI
FDA Product Code: PHX FDA UDI
KWT FDA UDI
HSD FDA UDI
GMDN Term: Stem-fixed metallic humeral head 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

Yes

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: Stem-fixed metallic humeral head prosthesis

FX V135 Shoulder Prosthesis by Fx Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stem-fixed metallic humeral head prosthesis.

MRS — Howmedica Osteonics Corp. · Class II
FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC. · Class II
FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
Equinoxe — Exactech, Inc. · Class II
TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II

Cleared under the same submission

K213117 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Fx Solutions

Sources (1)

FDA UDI 6b02275b-c70d-433a-b5d8-becca55ec36e 34 fields · synced Jun 8, 2026