OLYMPIC Posterior Spinal Fixation System
FDA 510(k) K153446 · Astura Medical
510(k) numberK153446
Submission
- Device name
- OLYMPIC Posterior Spinal Fixation System
- Applicant
- Astura Medical
Carlsbad, CA, US - Received
- November 27, 2015
- Decision date
- April 8, 2016
- 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 |
|---|---|---|---|
| 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 |
| K131615 | Polaris Spinal SystemOSH · Traditional | Biomet Spine (Aka Ebi, LLC) | 09/04/2013SE |
| 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 |
|---|---|---|
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemPML · Traditional | 01/22/2026SE |
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemNKB · Traditional | 10/21/2025SE |
| K243259 | MASADA Modular Spinal Fixation SystemNKB · Traditional | 01/07/2025SE |
| K240160 | EGPS Navigated InstrumentsOLO · Traditional | 10/17/2024SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | 03/08/2024SE |
| K231694 | MASADA Modular Spinal Fixation SystemNKB · Traditional | 11/16/2023SE |
| K232211 | REUNION Sacroiliac Joint Fusion SystemOUR · Traditional | 10/24/2023SE |
| K223335 | SIRION Lateral Lumbar Interbody SystemMAX · Traditional | 05/09/2023SE |
| K222097 | OLYMPIC Deformity Band SystemOWI · Traditional | 05/04/2023SE |
| K222554 | EL CAPITAN Anterior Lumbar Interbody FusionOVD · Traditional | 01/19/2023SE |
Questions and answers
When was OLYMPIC Posterior Spinal Fixation System cleared by the FDA?
OLYMPIC Posterior Spinal Fixation System (K153446) received a 510(k) decision of Substantially Equivalent on April 8, 2016, 133 days after the submission was received.
What is the product code of K153446?
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.