FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System
K Number: K191212
·
Decision Sep 24, 2019
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
13
Applicant Total
96
Review Days
141
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Basic Information
- Device Name
- CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System
- K Number
- K191212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medos International SARL
- Date Received
- May 6, 2019
- Decision Date
- September 24, 2019
- Product Code
- PGM
- 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 |
|---|---|---|---|
| PGM | Growing Rod System | FDA class 2 | Orthopedic |
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Other Clearances by Medos International SARL
| K Number | Device Name | ||
|---|---|---|---|
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| K260240 | SYMPHONY Navigation Ready Instruments | Mar 27, 2026 | Substantially Equivalent |
| K253249 | TriALTIS Spine System | Oct 21, 2025 | Substantially Equivalent |
| K243249 | TriALTIS Spine System | Jan 17, 2025 | Substantially Equivalent |
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Sep 16, 2024 | Substantially Equivalent |
| K242042 | TriALTIS Spine System | Sep 9, 2024 | Substantially Equivalent |
| K233684 | TriALTIS Spine System | Dec 12, 2023 | Substantially Equivalent |
| K233366 | SYMPHONY OCT System | Nov 9, 2023 | Substantially Equivalent |
| K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor | Oct 6, 2023 | Substantially Equivalent |
| K231479 | TriALTIS Spine System | Sep 22, 2023 | Substantially Equivalent |