FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
K Number: K171421
·
Decision Jan 10, 2018
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
10
Review Days
240
Basic Information
- Device Name
- VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
- K Number
- K171421
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Silony Medical GmbH
- Date Received
- May 15, 2017
- Decision Date
- January 10, 2018
- 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 Silony Medical GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K223806 | VERTICALE® Triangular Fixation System | Jul 6, 2023 | Substantially Equivalent |
| K223649 | VERTICALE® Navigation Instruments | Dec 22, 2022 | Substantially Equivalent |
| K212007 | VERTICALE Navigation Instruments | Aug 12, 2021 | Substantially Equivalent |
| K192013 | VERTICALE® Cervical System | Apr 7, 2020 | 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 |
| K171434 | ROCCIA® MultiLIF | Dec 21, 2017 | Substantially Equivalent |