← Back to catalogue

Catalyst CSR Shoulder System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K152825

by Catalyst Orthoscience, LLC

Identity

Trade Name
Catalyst CSR Shoulder System FDA UDI
Generic Name
Resurfacing humeral head prosthesis FDA UDI
Device Name
Humeral Implant, Size C FDA UDI
Model / Reference
1226-7200-003 FDA UDI
Description
Humeral Implant, Size C FDA UDI

Identifiers

Primary DI / UDI-DI
00851388006081 FDA UDI
510(k) Number
K152825 FDA 510(k)FDA UDI
FDA Product Code
KWT FDA 510(k)FDA UDI
HSD FDA UDI
GMDN Term
Resurfacing humeral head prosthesis FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3650 FDA 510(k)
Regulation Number
888.3650 FDA 510(k)FDA UDI
888.3690 FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

Yes

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

Catalyst CSR Shoulder System by Catalyst Orthoscience, LLC — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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

Manufacturer

Manufacturer
Catalyst Orthoscience, LLC

Sources (2)

  • FDA 510(k) K152825 24 fields · synced Jun 19, 2026
  • FDA UDI 7d2d5834-a13c-48cc-bd35-53b1c29f55b2 35 fields · synced May 26, 2026