Signature Personalized Patient Care System - Glenoid Guide System
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K130126 FDA 510(k)
- FDA Product Code
- MBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3670 FDA 510(k)
- Regulation Number
- 888.3670 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Signature Personalized Patient Care System - Glenoid Guide System is a semi-constrained, metal and polymer, uncemented shoulder prosthesis. It is designed to assist in the surgical placement of glenoid components during shoulder arthroplasty procedures.
This device is authorized for use under FDA 510(k) clearance. It is categorized under orthopedic regulation number 888.3670.
Frequently asked questions
What is the primary purpose of the Signature Personalized Patient Care System?
This system is designed to assist surgeons in the accurate placement of glenoid components during shoulder arthroplasty procedures.
What type of device is the Glenoid Guide System?
It is a semi-constrained, metal and polymer, uncemented shoulder prosthesis used in orthopedic surgical applications.
Under what regulatory framework is this device authorized?
The device is authorized for use under FDA 510(k) clearance, specifically categorized under orthopedic regulation number 888.3670.
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: Free Online Digital Signature Maker - Docusign
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130126 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K130126 24 fields · synced Sep 23, 2026