FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Spinal System
K Number: K142576
·
Decision Feb 26, 2015
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
8
Review Days
167
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Basic Information
- Device Name
- Spinal System
- K Number
- K142576
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eisertech, LLC
- Date Received
- September 12, 2014
- Decision Date
- February 26, 2015
- 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 Eisertech, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K192768 | Temporary Fixation Pins | Dec 26, 2019 | Substantially Equivalent |
| K190565 | Cervical Plate | May 31, 2019 | Substantially Equivalent |
| K140348 | INTERBODY CAGE | Apr 23, 2015 | Substantially Equivalent |
| K122444 | CERVICAL CAGE | Aug 30, 2012 | Substantially Equivalent |
| K113170 | CERVICAL PLATE | Apr 6, 2012 | Substantially Equivalent |
| K113478 | PLIF CAGE | Mar 5, 2012 | Substantially Equivalent |
| K110915 | CERVICAL CAGE | Jul 22, 2011 | Substantially Equivalent |