CSR Shoulder System

FDA UDI

Class II (US FDA UDI)

by CATALYST ORTHOSCIENCE Inc

Identity

Trade Name: CSR Shoulder System FDA UDI
Generic Name: Resurfacing humeral head prosthesis FDA UDI
Device Name: Press-Fit Humeral Implant Size B FDA UDI
Model / Reference: 1228-7300-002 FDA UDI
Description: Press-Fit Humeral Implant Size B FDA UDI

Identifiers

Primary DI / UDI-DI: 00811596030001 FDA UDI
510(k) Number: K182500 FDA UDI
FDA Product Code: HSD FDA UDI
GMDN Term: Resurfacing humeral head prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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: Resurfacing humeral head prosthesis

CSR Shoulder System by CATALYST ORTHOSCIENCE Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Resurfacing humeral head prosthesis.

AEQUALIS RESURFACING HEAD — TORNIER, INC. · Class II
SMR System — Limacorporate · Class II
COPELAND EAS SHOULDER SYSTEM — Biomet Orthopedics, Inc. · Class II
Equinoxe — Exactech, Inc. · Class II
Titan™ Reverse Shoulder System — Ascension Orthopedics, Inc. · Class II
Titan™ — Ascension Orthopedics, Inc. · Class II
Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class II
Titan™ Reverse Shoulder System — Ascension Orthopedics, Inc. · Class II

Cleared under the same submission

K182500 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: CATALYST ORTHOSCIENCE Inc

Sources (1)

FDA UDI c98a8009-49c6-4876-98a4-8642db117290 35 fields · synced Jun 8, 2026