Piccolo Composite Nailing System
FDA 510(k) K151010 · CarboFix Orthopedics , Ltd.
510(k) numberK151010
Submission
- Device name
- Piccolo Composite Nailing System
- Applicant
- CarboFix Orthopedics , Ltd.
Herzliya, IL - Received
- April 15, 2015
- Decision date
- July 28, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
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| K233793 | CarboClear® X Pedicle Screw SystemNKB · Traditional | 08/01/2024SE |
| K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…NKB · Special | 04/25/2024SE |
| K233989 | CarboClear® Posterior Cervical Screw SystemNKG · Traditional | 03/27/2024SE |
| K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsNKB · Special | 01/10/2024SE |
| K232341 | CarboClear® Pedicle Screw SystemNKB · Traditional | 10/10/2023SE |
| K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…NKB · Traditional | 07/03/2023SE |
| K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsNKB · Special | 04/06/2021SE |
| K203317 | CarboClear X Pedicle Screw SystemNKB · Special | 11/25/2020SE |
Questions and answers
When was Piccolo Composite Nailing System cleared by the FDA?
Piccolo Composite Nailing System (K151010) received a 510(k) decision of Substantially Equivalent on July 28, 2015, 104 days after the submission was received.
What is the product code of K151010?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.