Controlled Delivery for Osteoplasty (CDO System) and Graft Preparation System
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K072330 FDA 510(k)
- FDA Product Code
- FMF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Controlled Delivery for Osteoplasty (CDO System) and Graft Preparation System is a medical device classified as a Syringe, Piston (product code FMF). It is designed for use in osteoplasty procedures and graft preparation, providing controlled delivery capabilities during surgical interventions.
This device is manufactured by Biomet, Inc. and is supplied as a Class II medical device under special controls. It received FDA 510(k) clearance on December 6, 2007, with K number K072330. The system is intended for use in hospital settings, though specific details regarding sterility, single-use or reusable status, MRI safety, and storage conditions are not provided in the available data.
Frequently asked questions
What is the CDO System used for in medical procedures?
The CDO System is designed for use in osteoplasty procedures and graft preparation, providing controlled delivery capabilities during surgical interventions. It is classified as a Syringe, Piston (product code FMF) and intended for hospital settings.
What is the regulatory status of the CDO System?
The CDO System received FDA 510(k) clearance on December 6, 2007, with K number K072330. It is manufactured by Biomet, Inc. and supplied as a Class II medical device under special controls.
Is the CDO System single-use or reusable?
The available data does not specify whether the CDO System is single-use or reusable. Similarly, information regarding sterility status, MRI safety, and storage conditions is not provided in the device data.
What is the product code and classification of the CDO System?
The CDO System is classified as a Syringe, Piston with product code FMF. This classification indicates its primary function and design characteristics as a medical device for controlled delivery during surgical procedures.
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: Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation ..., K072330 FDA 510(k) - CONTROLLED DELIVERY FOR OSTEOPLASTY (CD..., PDF K072330 Controlled Delivery for Osteoplasty (Cdo System) and Graft ..., Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072330 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K072330 24 fields · synced Sep 22, 2026