FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VERTICALE® Cervical System
K Number: K192013
·
Decision Apr 7, 2020
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
12
Review Days
253
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Basic Information
- Device Name
- VERTICALE® Cervical System
- K Number
- K192013
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Silony Medical GmbH
- Date Received
- July 29, 2019
- Decision Date
- April 7, 2020
- Product Code
- NKG
- 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 |
|---|---|---|---|
| NKG | Posterior Cervical Screw System | FDA class 2 | Orthopedic |
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| K212007 | VERTICALE Navigation Instruments | Aug 12, 2021 | Substantially Equivalent |
| K190680 | FAVO S-TLIF | Jul 18, 2019 | Substantially Equivalent |
| K182608 | Oyster ACIF Cage | Jun 13, 2019 | Substantially Equivalent |
| K181899 | ROCCIA® PLIF | Dec 13, 2018 | Substantially Equivalent |
| K180963 | ROCCIA ALIF, ROCCIA TLIF | Jul 11, 2018 | Substantially Equivalent |
| K171421 | VERTICALE® Posterior Spinal Fixation System/VERTICALE® System | Jan 10, 2018 | Substantially Equivalent |
| K171434 | ROCCIA® MultiLIF | Dec 21, 2017 | Substantially Equivalent |