FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
ProMIS Extension Rod System
K Number: K232719
·
Decision Nov 21, 2023
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
6
Review Days
77
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Basic Information
- Device Name
- ProMIS Extension Rod System
- K Number
- K232719
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Premia Spine, Ltd.
- Date Received
- September 5, 2023
- Decision Date
- November 21, 2023
- 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 Premia Spine, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K231844 | ProMIS Fixation System | Jul 7, 2023 | Substantially Equivalent |
| K191854 | Premia Spine XL Instruments | Oct 8, 2019 | Substantially Equivalent |
| K182598 | VersaLink Fixation System | Nov 13, 2018 | Substantially Equivalent |
| K170061 | ProMIS Fixation System | Feb 2, 2017 | Substantially Equivalent |
| K150380 | ProMIS Fixation System | Jul 17, 2015 | Substantially Equivalent |