ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS— 510(k) K141509
Substantially EquivalentMedos Sarl
FDA 510(k) clearance K141509 for ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS, Substantially Equivalent on 2014-08-22. Applicant: Medos Sarl. Device class: 2.
Clearance details
- Applicant
- Medos Sarl
- Product code
- Code PGM
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raynham, MA, US
Recent devices under product code PGM
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- K213196 — MARVEL Growing Rods
- K193224 — Daytona® Small Stature Growth Rod Conversion Set
- K191212 — 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.