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
FDA 510(k) clearance K191212 · decided 2019-09-24
Clearance details
- K-number
- K191212
- 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
- Applicant
- Medos International SARL
- Decision
- Substantially Equivalent
- Date received
- 2019-05-06
- Decision date
- 2019-09-24
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- PGM
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Lelocle, CH
- Third-party review
- No
- Expedited review
- No
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| Polaris Spinal Growth System (K180227) | Zimmer Biomet Spine, Inc. | 2018-03-15 |
| NuVasive® Growth Rod Conversion Set (K172979) | Nu Vasive, Incorporated | 2017-11-06 |
| K2M Growing Spine System (K161028) | K2m, Inc. | 2016-07-22 |
| CD HORIZON Growth Rod Conversion Set (K150200) | Medtronic Sofamor Danek USA, Incorporated | 2015-02-25 |
| Xia® Growth Rod Conversion Set (K142114) | Stryker Corporation | 2014-10-27 |
| ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS (K141509) | Medos Sarl | 2014-08-22 |
| SHILLA GROWTH GUIDANCE SYSTEM (K140750) | Medtronic Sofamor Danek USA, Inc. | 2014-07-17 |
Recalls involving this device
No recalls on record reference this clearance.