Rsp Modular Glenoid Baseplate, Glenoid Taper Adapter, Retaining Screw
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K130550 FDA 510(k)
- FDA Product Code
- PHX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3660 FDA 510(k)
- Regulation Number
- 888.3660 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rsp Modular Glenoid Baseplate is a modular orthopedic implant component for reverse shoulder arthroplasty, serving as a multi-piece construct. It consists of a Glenoid Baseplate, Glenoid Taper Adapter, and Retaining Screw. This device is classified as a Shoulder Prosthesis, Reverse Configuration. The Rsp Modular Glenoid Baseplate is used in orthopedic procedures.
The device is supplied as a modular component and is intended for use in reverse shoulder arthroplasty. It has been assigned the product code PHX and has received FDA 510(k) clearance, with the clearance number K130550. The device is classified as a Class II device with Special Controls. It is manufactured by Encore Medical L.P. and has been cleared as Substantially Equivalent.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Rsp Modular Glenoid Baseplate, Glenoid Taper Adapter, Retaining Screw ..., K130550 FDA 510(k) - RSP MODULAR GLENOID BASEPLATE, PDF K130550 Rsp Modular Glenoid Baseplate, Glenoid Taper Adapter, Retaining ..., RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130550 | Class II | Active |
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Manufacturer
- Manufacturer
- Encore Medical L.P.
Sources (1)
- FDA 510(k) K130550 24 fields · synced Sep 27, 2026