Implanet Spine System
FDA 510(k) K132303 · Implanet, S.A.
510(k) numberK132303
Submission
- Device name
- Implanet Spine System
- Applicant
- Implanet, S.A.
Philedelphia, PA, US - Received
- July 24, 2013
- Decision date
- October 10, 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
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|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was Implanet Spine System cleared by the FDA?
Implanet Spine System (K132303) received a 510(k) decision of Substantially Equivalent on October 10, 2013, 78 days after the submission was received.
What is the product code of K132303?
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.