Pass LP Spinal System
FDA 510(k) K132574 · Medicrea International
510(k) numberK132574
Submission
- Device name
- Pass LP Spinal System
- Applicant
- Medicrea International
Neyron, FR - Received
- August 16, 2013
- Decision date
- November 8, 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 |
| 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 |
|---|---|---|
| K213659 | LigaPASS 2.0 Ligament Augmentation SystemOWI · Traditional | 05/24/2022SE |
| K220810 | Infinity OCT System and PASS OCT Spinal SystemNKG · Special | 04/19/2022SE |
| K220724 | CD Horizon Spinal System and PASS LP Spinal SystemNKB · Special | 04/08/2022SE |
| K212005 | UNiD Spine AnalyzerLLZ · Traditional | 01/12/2022SE |
| K213281 | PASS LP Spinal System, CD Horizon Spinal SystemNKB · Traditional | 01/05/2022SE |
| K210470 | C-CURVE Interbody Fusion DeviceOVE · Traditional | 09/03/2021SE |
| K200316 | UNiD IB3D ALIFMAX · Traditional | 10/30/2020SE |
| K191134 | IB3D AlifMAX · Traditional | 10/30/2019SE |
| K182158 | UNiD Patient-matched PLIF cageMAX · Traditional | 07/15/2019SE |
| K190092 | UNiD Patient specific 3D printed TLIF cageMAX · Traditional | 05/08/2019SE |
Questions and answers
When was Pass LP Spinal System cleared by the FDA?
Pass LP Spinal System (K132574) received a 510(k) decision of Substantially Equivalent on November 8, 2013, 84 days after the submission was received.
What is the product code of K132574?
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.