FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PIEZOELECTRIC SYSTEM
K Number: K100410
·
Decision Apr 28, 2010
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
22
Applicant Total
24
Review Days
71
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Basic Information
- Device Name
- PIEZOELECTRIC SYSTEM
- K Number
- K100410
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.4580
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Satelec
- Date Received
- February 16, 2010
- Decision Date
- April 28, 2010
- Product Code
- JDX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | FDA class 2 | Orthopedic |
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Other Clearances by Satelec
| K Number | Device Name | ||
|---|---|---|---|
| K110379 | AIR-N-GO | Dec 8, 2011 | Substantially Equivalent |
| K091331 | PIEZOTOME 2 | Dec 11, 2009 | Substantially Equivalent |
| K091252 | IMPLANT CENTER 2 | Jul 22, 2009 | Substantially Equivalent |
| K082116 | HEMOSTASYL PASTE | Dec 17, 2008 | Substantially Equivalent |
| K072181 | MINI LED AUTOFOCUS | Sep 19, 2007 | Substantially Equivalent |
| K071965 | I-SURGE | Sep 10, 2007 | Substantially Equivalent |
| K060275 | PIEZOTOME | May 3, 2006 | Substantially Equivalent |
| K060274 | PIEZOTOME | May 1, 2006 | Substantially Equivalent |
| K053328 | BIOSPLINT SPLINTING RIBBON | Jan 25, 2006 | Substantially Equivalent |
| K050895 | SURPASSON P5 NEWTRON | Apr 20, 2005 | Substantially Equivalent |