FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Sterispine PS
K Number: K201648
·
Decision Jul 30, 2020
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
13
Review Days
42
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Basic Information
- Device Name
- Sterispine PS
- K Number
- K201648
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Safe Orthopaedics
- Date Received
- June 18, 2020
- Decision Date
- July 30, 2020
- 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 Safe Orthopaedics
| K Number | Device Name | ||
|---|---|---|---|
| K170528 | Sterispine PS | Mar 9, 2017 | Substantially Equivalent |
| K162531 | STERISPINE CC | Dec 29, 2016 | Substantially Equivalent |
| K151921 | STERISPINE PS | Oct 8, 2015 | Substantially Equivalent |
| K151747 | STERISPINE PS | Oct 5, 2015 | Substantially Equivalent |
| K151756 | STERISPINE LC CAGE | Aug 21, 2015 | Substantially Equivalent |
| K150092 | STERISPINE PS Pedicle Screw | Feb 10, 2015 | Substantially Equivalent |
| K140802 | STERISPINE PS | Jun 4, 2014 | Substantially Equivalent |
| K133893 | STERISPINE LC CAGE | Mar 14, 2014 | Substantially Equivalent |
| K130632 | STERISPINE PS PEDICLE SCREW | May 3, 2013 | Substantially Equivalent |
| K122021 | STERISPINE LC CAGE | Sep 20, 2012 | Substantially Equivalent |