Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System
FDA 510(k) K072330 · Biomet, Inc.
510(k) numberK072330
Submission
- Device name
- Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- August 20, 2007
- Decision date
- December 6, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | CMT Health PTE., Ltd. | 02/23/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
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Questions and answers
When was Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System cleared by the FDA?
Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System (K072330) received a 510(k) decision of Substantially Equivalent on December 6, 2007, 108 days after the submission was received.
What is the product code of K072330?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.