Kleiner Device Labs
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| Abbreviation | KDL |
|---|---|
| Nickname | Kleiner Labs |
| Predecessor | Spinal Surgical Strategies, LLC |
| Founder | Jeffrey B. Kleiner, MD |
| Founded at | Incline Village, Nevada |
| Type | C Corporation |
| Legal status | Company |
| Purpose | Improving instruments & outcomes for spine surgery while lowering costs for patients, surgeons, hospitals, and payers.[1] |
| Headquarters | Incline Village, Nevada |
| Location | |
| Origins | Surgeon research on bone graft dispersion/volume and clinical outcomes[2] |
| Products | Spinal fusion Implants Bone grafting Instrumentation [3] |
| Fields | Medtech[4] |
Key people | Jeffrey B. Kleiner, MD (CEO), Alan Burkholder (CTO) |
| Award(s) | 2022 Medical Design Excellence Awards (Implant and Tissue-Replacement Products category)[5][6] |
| Website | kleinerlabs.com |
Formerly called | Spinal Surgical Strategies, LLC |
Kleiner Device Labs is a medical device company focused on the development of Implants and Bone grafting Instrumentation for spine surgery.[7] The company was founded in 2013 by Stanford graduate and spine surgeon Jeffrey B. Kleiner, MD (after 25+ years of active surgical practice).[8] The organization maintains a portfolio of 23 patents for its technologies.[citation needed][9]
FDA 510(k) cleared products[edit]
- KG2 System - FDA cleared on September 14, 2021.[10] First use in patient on July 19, 2022.[11][12][13]
- KG1 Bi-Portal Bone Graft Delivery Device - FDA cleared on December 11, 2014.[14] Commercially available January 11, 2018.[15][16]
References[edit]
- ↑ Labs, Kleiner Device. "Kleiner Device Labs". Kleiner Device Labs.
- ↑ Kleiner, Jeffrey B.; Kleiner, Hannah M.; Jr, E. John Grimberg; Throlson, Stefanie J. (May 13, 2016). "Evaluation of a novel tool for bone graft delivery in minimally invasive transforaminal lumbar interbody fusion". Medical Devices: Evidence and Research. 9: 105–114. doi:10.2147/MDER.S100098. PMC 4876849. PMID 27274320 – via www.dovepress.com.
- ↑ "Graft Delivery Device Market Major Developments and Competition Landscape by 2030".
- ↑ Kumar, Sweeny (May 17, 2021). "Kleiner Device Labs on Equifund CFP". KingsCrowd.
- ↑ "2022 Medical Design Excellence Awards Winners". mddionline.com. April 6, 2022.
- ↑ "Kleiner Device Labs' KG2 Surge flow-thru interbody system named finalist for MD+DI Medical Design Excellence Award | Spinal Surgery News". www.spinalsurgerynews.com.
- ↑ Condon, Alan. "23 spine device companies to watch in 2022". www.beckersspine.com. Retrieved 2022-08-26.
- ↑ Tudoran, Paula (2022-01-27). "This Medical Startup Could Disrupt The $14 Billion Spinal Fusion Market: Last Call To Invest". Benzinga. Retrieved 2022-08-26.
- ↑ "Becker's named 23 spine device companies to watch in 2022: Where are they now?".
- ↑ Health, Center for Devices and Radiological (2021-10-18). "September 2021 510(K) Clearances". FDA.
- ↑ "Leading Spine Surgeon at The Brooklyn Hospital Center First to Perform New Spinal Fusion Procedure". The Brooklyn Hospital Center. 2022-08-01. Retrieved 2022-08-26.
- ↑ Behm, Carly. "Dr. Anders Cohen debuts Kleiner Device Labs interbody system". www.beckersspine.com. Retrieved 2022-08-26.
- ↑ Vetalice, Julie A. (August 1, 2022). "First Case with Kleiner Device Labs' KG2 Surge Flow-Thru Interbody". Orthoworld. Retrieved August 26, 2022.
- ↑ "510(k) Premarket Notification". www.accessdata.fda.gov. Retrieved 2022-08-26.
- ↑ "Kleiner introduces new spinal bone graft delivery tool". NS Medical Devices. 2018-01-11. Retrieved 2022-08-26.
- ↑ "Research". www.healthpointcapital.com. Retrieved 2022-08-26.
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