FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
JAZZ FRAME SYSTEM
K Number: K162764
·
Decision Jan 19, 2017
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
15
Review Days
111
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Basic Information
- Device Name
- JAZZ FRAME SYSTEM
- K Number
- K162764
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implanet, S.A.
- Date Received
- September 30, 2016
- Decision Date
- January 19, 2017
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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Other Clearances by Implanet, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K230026 | SQUALE | Mar 28, 2023 | Substantially Equivalent |
| K192084 | Madison Total Knee System | Oct 22, 2019 | Substantially Equivalent |
| 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 |
| 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 |
| K143759 | JAZZ System | May 7, 2015 | Substantially Equivalent |