FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Diplomat® Spinal System
K Number: K151704
·
Decision Apr 13, 2016
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
23
Review Days
294
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Basic Information
- Device Name
- Diplomat® Spinal System
- K Number
- K151704
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Signus Medizintechnik GmbH
- Date Received
- June 24, 2015
- Decision Date
- April 13, 2016
- 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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| K141405 | MOBIS II ST SPINAL IMPLANT | Sep 16, 2014 | Substantially Equivalent |
| K123758 | TASMIN R | Jan 14, 2014 | Substantially Equivalent |
| K131372 | MOBIS II | Jul 2, 2013 | Substantially Equivalent |
| K122317 | TETRIS II | Aug 29, 2012 | Substantially Equivalent |
| K111792 | MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI | Mar 5, 2012 | Substantially Equivalent |
| K090387 | KAINOS+ | Sep 28, 2009 | Substantially Equivalent |