FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Renaissance X System
K Number: K152041
·
Decision Nov 17, 2015
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
13
Review Days
118
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Basic Information
- Device Name
- Renaissance X System
- K Number
- K152041
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mazor Robotics , Ltd.
- Date Received
- July 22, 2015
- Decision Date
- November 17, 2015
- Product Code
- OLO
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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|---|---|---|---|
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| K203005 | Mazor X | Oct 27, 2020 | Substantially Equivalent |
| K200935 | Mazor X | May 8, 2020 | Substantially Equivalent |
| K182077 | Mazor X System (Mazor X Stealth Edition) | Nov 2, 2018 | Substantially Equivalent |
| K180307 | Mazor X | Apr 30, 2018 | Substantially Equivalent |
| K172522 | Mazor X | Sep 15, 2017 | Substantially Equivalent |
| K163221 | Mazor X | Apr 4, 2017 | Substantially Equivalent |
| K140167 | RENAISSANCE X SYSTEM | Sep 10, 2014 | Substantially Equivalent |
| K120812 | RENAISSANCE | Jul 12, 2012 | Substantially Equivalent |