Piezoelectric System
FDA 510(k) K100410 · Satelec
510(k) numberK100410
Submission
- Device name
- Piezoelectric System
- Applicant
- Satelec
Mt. Laurel, NJ, US - Received
- February 16, 2010
- Decision date
- April 28, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDX – Instrument, Surgical, Sonic And Accessory/Attachment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4580
- Specialty
- Orthopedic
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| K060275 | PiezotomeELC · Traditional | 05/03/2006SE |
| K060274 | PiezotomeDZI · Traditional | 05/01/2006SE |
| K053328 | Biosplint Splinting RibbonEBI · Traditional | 01/25/2006SE |
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Questions and answers
When was Piezoelectric System cleared by the FDA?
Piezoelectric System (K100410) received a 510(k) decision of Substantially Equivalent on April 28, 2010, 71 days after the submission was received.
What is the product code of K100410?
The FDA product code is JDX – Instrument, Surgical, Sonic And Accessory/Attachment, a Class II (moderate risk) device regulated under 21 CFR 888.4580.