FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JAZZ SYSTEM
K Number: K121541
·
Decision Sep 13, 2012
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
128
Applicant Total
15
Review Days
112
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Basic Information
- Device Name
- JAZZ SYSTEM
- K Number
- K121541
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implanet, S.A.
- Date Received
- May 24, 2012
- Decision Date
- September 13, 2012
- Product Code
- JDQ
- 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Implanet, S.A.
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|---|---|---|---|
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| K191217 | JAZZ PF | Aug 2, 2019 | Substantially Equivalent |
| K182771 | ISS-JAZZ Screw System and JAZZ CAP SP | Mar 12, 2019 | Substantially Equivalent |
| K171881 | JAZZ Passer Band | Aug 8, 2017 | Substantially Equivalent |
| K170730 | JAZZ System, including JAZZ Band | Jun 9, 2017 | Substantially Equivalent |
| K162764 | JAZZ FRAME SYSTEM | Jan 19, 2017 | Substantially Equivalent |
| K160226 | JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector | May 18, 2016 | Substantially Equivalent |
| K153348 | JAZZ LOCK | Mar 31, 2016 | Substantially Equivalent |
| K151740 | JAZZ System | Aug 27, 2015 | Substantially Equivalent |