Isola and Expedium Growing Spine Systems
FDA 510(k) K141509 · Medos Sarl
510(k) numberK141509
Submission
- Device name
- Isola and Expedium Growing Spine Systems
- Applicant
- Medos Sarl
Raynham, MA, US - Received
- June 6, 2014
- Decision date
- August 22, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGM – Growing Rod System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Stabilization or correction of spinal deformities without the use of fusion.
Other 510(k)s with product code PGM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251961 | SDS Growing RodPGM · Traditional | BAAT Medical Products B.V. | 01/15/2026SE |
| K241816 | VerteGlide Spinal Growth Guidance SystemPGM · Traditional | OrthoPediatrics Corp. | 03/14/2025SE |
| K213196 | MARVEL Growing RodsPGM · Traditional | Globus Medical, Inc. | 12/19/2022SE |
| K193224 | Daytona® Small Stature Growth Rod Conversion SetPGM · Traditional | SeaSpine Orthopedics Corporation | 02/13/2020SE |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…PGM · Traditional | Medos International SARL | 09/24/2019SE |
| K181068 | CREO® Stabilization System, REVERE® Stabilization SystemPGM · Traditional | Globus Medical, Inc. | 06/29/2018SE |
| K180227 | Polaris Spinal Growth SystemPGM · Traditional | Zimmer Biomet Spine, Inc. | 03/15/2018SE |
| K172979 | NuVasive® Growth Rod Conversion SetPGM · Traditional | Nu Vasive, Incorporated | 11/06/2017SE |
| K161028 | K2M Growing Spine SystemPGM · Traditional | K2m, Inc. | 07/22/2016SE |
| K150200 | CD HORIZON Growth Rod Conversion SetPGM · Special | Medtronic Sofamor Danek USA, Incorporated | 02/25/2015SE |
Questions and answers
When was Isola and Expedium Growing Spine Systems cleared by the FDA?
Isola and Expedium Growing Spine Systems (K141509) received a 510(k) decision of Substantially Equivalent on August 22, 2014, 77 days after the submission was received.
What is the product code of K141509?
The FDA product code is PGM – Growing Rod System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.