Polaris Spinal System
FDA 510(k) K131615 · Biomet Spine (Aka Ebi, LLC)
510(k) numberK131615
Submission
- Device name
- Polaris Spinal System
- Applicant
- Biomet Spine (Aka Ebi, LLC)
Parsippany, NJ, US - Received
- June 3, 2013
- Decision date
- September 4, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OSH – Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
Other 510(k)s with product code OSH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153446 | OLYMPIC Posterior Spinal Fixation SystemOSH · Traditional | Astura Medical | 04/08/2016SE |
| K140276 | CD Horizon Spinal SystemOSH · Traditional | Medtronic Sofamor Danek | 03/13/2014SE |
| K132574 | Pass LP Spinal SystemOSH · Traditional | Medicrea International | 11/08/2013SE |
| K132303 | Implanet Spine SystemOSH · Traditional | Implanet, S.A. | 10/10/2013SE |
| K132575 | Pass LP Spinal SystemOSH · Special | Medicrea International | 10/03/2013SE |
| K131802 | Expedium, Viper. Viper 2 Spine SystemOSH · Special | Depuy Spine, A Johnson & Johnson Company | 09/12/2013SE |
| K131784 | Range Spinal SystemOSH · Special | K2m, Inc. | 08/30/2013SE |
| K131321 | CD Horizon Spinal SystemOSH · Special | Medtronic Sofamor Danek USA | 06/05/2013SE |
| K124058 | Creo Stabilization SystemOSH · Traditional | Globus Medical, Inc. | 05/13/2013SE |
| K131030 | Range Spinal SystemOSH · Special | K2m, Inc. | 05/09/2013SE |
More from K2m, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K133518 | Maxan Anterior Cervical Plate SystemKWQ · Traditional | 11/05/2014SE |
| K140710 | Biomet Graft Delivery SyringesFMF · Traditional | 09/04/2014SE |
| K132373 | Biomet Access SystemPDQ · Traditional | 03/27/2014SE |
| K133746 | Polaris Spinal SystemNKB · Traditional | 03/12/2014SE |
| K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemNKB · Traditional | 02/25/2013SE |
| K123451 | Polaris Spinal System - Ballista II RodsNKB · Special | 12/03/2012SE |
| K122989 | Biomet Lateral Spacer SystemMAX · Traditional | 10/24/2012SE |
| K122378 | Nextgen Altius Oct SystemKWP · Special | 09/20/2012SE |
| K113593 | Nextgen Altius Oct SystemKWP · Traditional | 04/17/2012SE |
| K110650 | Zyston Arc Interbody SpacerMAX · Traditional | 06/30/2011SE |
Questions and answers
When was Polaris Spinal System cleared by the FDA?
Polaris Spinal System (K131615) received a 510(k) decision of Substantially Equivalent on September 4, 2013, 93 days after the submission was received.
What is the product code of K131615?
The FDA product code is OSH – Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis, a Class II (moderate risk) device regulated under 21 CFR 888.3070.