Range Spinal System, Small Stature
FDA 510(k) K122877 · K2m, Inc.
510(k) numberK122877
Submission
- Device name
- Range Spinal System, Small Stature
- Applicant
- K2m, Inc.
Leesburg, VA, US - Received
- September 19, 2012
- Decision date
- May 8, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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.
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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 |
| 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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| K252873 | Q Interbody InstrumentsOLO · Traditional | 02/06/2026SE |
| K211320 | CAPRI Corpectomy Cage SystemPLR · Traditional | 02/24/2022SE |
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| K193203 | MOJAVE Expandable Interbody SystemMAX · Special | 02/18/2020SE |
| K193129 | Yukon OCT Spinal SystemNKG · Traditional | 02/07/2020SE |
| K192911 | Brainlab Compatible K2M Navigation InstrumentsOLO · Special | 11/14/2019SE |
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Questions and answers
When was Range Spinal System, Small Stature cleared by the FDA?
Range Spinal System, Small Stature (K122877) received a 510(k) decision of Substantially Equivalent on May 8, 2013, 231 days after the submission was received.
What is the product code of K122877?
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.