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R1 Reverse Shoulder System

FDA UDI

Class II (US FDA UDI)

by CATALYST ORTHOSCIENCE Inc

Identity

Trade Name
R1 Reverse Shoulder System FDA UDI
Generic Name
Shoulder reverse/standard adaptor prosthesis trial FDA UDI
Device Name
Poly Trail 32mm +4mm FDA UDI
Model / Reference
1230-4211-002 FDA UDI
Description
Poly Trail 32mm +4mm FDA UDI

Identifiers

Primary DI / UDI-DI
00811596030933 FDA UDI
510(k) Number
K202611 FDA UDI
FDA Product Code
PHX FDA UDI
GMDN Term
Shoulder reverse/standard adaptor prosthesis trial 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Shoulder reverse/standard adaptor prosthesis trial

R1 Reverse Shoulder System by CATALYST ORTHOSCIENCE Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Shoulder reverse/standard adaptor prosthesis trial.

Cleared under the same submission

K202611 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CATALYST ORTHOSCIENCE Inc

Sources (1)

  • FDA UDI b452cb1f-d14e-4ab7-b796-71c32fbec3a7 36 fields · synced May 31, 2026