Polaris Spinal System - Ballista II Percutaneous Screw Placement System
FDA 510(k) K123549 · Biomet Spine (Aka Ebi, LLC)
510(k) numberK123549
Submission
- Device name
- Polaris Spinal System - Ballista II Percutaneous Screw Placement System
- Applicant
- Biomet Spine (Aka Ebi, LLC)
Parsippany, NJ, US - Received
- November 19, 2012
- Decision date
- February 25, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Other 510(k)s with product code NKB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 09/04/2026SE |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…NKB · Traditional | MANTIZ Co., Ltd. | 07/24/2026SE |
| K253943 | Tiger 2 SystemNKB · Traditional | Zavation Medical Products, LLC | 07/24/2026SE |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional | Alphatec Spine, Inc. | 07/14/2026SE |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 07/01/2026SE |
| K253045 | Socko Vimax Spinal Fixation SystemNKB · Traditional | Socko Medical Co., Ltd. | 06/17/2026SE |
| K251251 | ChanPin Pedicle Screw Spinal SystemNKB · Traditional | Chanpin Medtak Co., Ltd. | 06/09/2026SE |
| K260989 | Varion Thoracolumbar Fixation SystemNKB · Traditional | Kyocera Medical Technologies Inc. (KMTI) | 05/15/2026SE |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional | Globus Medical, Inc. | 05/07/2026SE |
| K261130 | AccelFix Spinal Fixation SystemNKB · Special | L&K BIOMED Co., Ltd. | 05/05/2026SE |
More from L&K BIOMED Co., Ltd.
| 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 |
| K131615 | Polaris Spinal SystemOSH · Traditional | 09/04/2013SE |
| 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 - Ballista II Percutaneous Screw Placement System cleared by the FDA?
Polaris Spinal System - Ballista II Percutaneous Screw Placement System (K123549) received a 510(k) decision of Substantially Equivalent on February 25, 2013, 98 days after the submission was received.
What is the product code of K123549?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.