Op Spine System
FDA 510(k) K120291 · OrthoPediatrics Corp.
510(k) numberK120291
Submission
- Device name
- Op Spine System
- Applicant
- OrthoPediatrics Corp.
Warsaw, IN, US - Received
- January 31, 2012
- Decision date
- April 16, 2012
- Decision
- Unknown (SESU)
- 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 |
| 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 |
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| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurHSB · Special | 04/01/2025SE |
| K241816 | VerteGlide Spinal Growth Guidance SystemPGM · Traditional | 03/14/2025SE |
| K243798 | Orthex External Fixation SystemKTT · Traditional | 03/07/2025SE |
| K233105 | RESPONSE Rib and Pelvic SystemMDI · Traditional | 01/20/2024SE |
| K231266 | Pediatric Nailing Platform TibiaHSB · Traditional | 08/21/2023SE |
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Questions and answers
When was Op Spine System cleared by the FDA?
Op Spine System (K120291) received a 510(k) decision of Unknown on April 16, 2012, 76 days after the submission was received.
What is the product code of K120291?
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.