FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
JAZZ System
K Number: K151740
·
Decision Aug 27, 2015
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
36
Applicant Total
15
Review Days
62
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Basic Information
- Device Name
- JAZZ System
- K Number
- K151740
- 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
- June 26, 2015
- Decision Date
- August 27, 2015
- Product Code
- OWI
- 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 |
|---|---|---|---|
| OWI | Bone Fixation Cerclage, Sublaminar | 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 |
| 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 |
| K143759 | JAZZ System | May 7, 2015 | Substantially Equivalent |