Identity
- Trade Name
- R1 Reverse Shoulder System FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Peripheral Drill Guide ASM FDA UDI
- Model / Reference
- 1230-5207 FDA UDI
- Description
- Peripheral Drill Guide ASM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811596031084 FDA UDI
- 510(k) Number
- K202611 FDA UDI
- FDA Product Code
- PHX FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable 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
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
R1 Reverse Shoulder System by CATALYST ORTHOSCIENCE Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202611 also covers:
- R1 Reverse Shoulder System — CATALYST ORTHOSCIENCE Inc
- R1 Reverse Shoulder System — CATALYST ORTHOSCIENCE Inc
- R1 Reverse Shoulder System — CATALYST ORTHOSCIENCE Inc
- R1 Reverse Shoulder System — CATALYST ORTHOSCIENCE Inc
- R1 Reverse Shoulder System — CATALYST ORTHOSCIENCE Inc
- R1 Reverse Shoulder System — CATALYST ORTHOSCIENCE Inc
- R1 Reverse Shoulder System — CATALYST ORTHOSCIENCE Inc
- R1 Reverse Shoulder System — CATALYST ORTHOSCIENCE Inc
- R1 Reverse Shoulder System — CATALYST ORTHOSCIENCE Inc
- R1 Reverse Shoulder System — CATALYST ORTHOSCIENCE Inc
- R1 Reverse Shoulder System — CATALYST ORTHOSCIENCE Inc
- R1 Reverse Shoulder System — CATALYST ORTHOSCIENCE Inc
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 88ae8622-39ce-4056-9884-0540fc2cbe57 36 fields · synced May 30, 2026