Draft:Kleiner Device Labs

  • Comment: There's been no substantive change here since the last decline (which, by the way, I endorse). Please do not waste the precious time and goodwill of volunteer AfC reviewers (and, incidentally, also your own) by re-submitting the same content for a second review. Our notability requirements for companies are here, our disclosure requirements for paid editors are here, please take note of both. Justlettersandnumbers (talk) 20:14, 5 September 2022 (UTC)
  • Comment: This is yet again, sourced almost entirely to basic PR announcements with no in depth coverage. PICKLEDICAE🥒 15:49, 27 August 2022 (UTC)
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Kleiner Device Labs
AbbreviationKDL
NicknameKleiner Labs
PredecessorSpinal Surgical Strategies, LLC
FounderJeffrey B. Kleiner, MD
Founded atIncline Village, Nevada
TypeC Corporation
Legal statusCompany
PurposeImproving instruments & outcomes for spine surgery while lowering costs for patients, surgeons, hospitals, and payers.[1]
HeadquartersIncline Village, Nevada
Location
OriginsSurgeon research on bone graft dispersion/volume and clinical outcomes[2]
ProductsSpinal fusion Implants Bone grafting Instrumentation [3]
FieldsMedtech[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]
Websitekleinerlabs.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

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  • 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

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  1. ^ Labs, Kleiner Device. "Kleiner Device Labs". Kleiner Device Labs.
  2. ^ 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.
  3. ^ "Graft Delivery Device Market Major Developments and Competition Landscape by 2030".
  4. ^ Kumar, Sweeny (May 17, 2021). "Kleiner Device Labs on Equifund CFP". KingsCrowd.
  5. ^ "2022 Medical Design Excellence Awards Winners". mddionline.com. April 6, 2022.
  6. ^ "Kleiner Device Labs' KG2 Surge flow-thru interbody system named finalist for MD+DI Medical Design Excellence Award | Spinal Surgery News". www.spinalsurgerynews.com. 5 April 2022.
  7. ^ Condon, Alan (25 February 2022). "23 spine device companies to watch in 2022". www.beckersspine.com. Retrieved 2022-08-26.
  8. ^ 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.
  9. ^ "Becker's named 23 spine device companies to watch in 2022: Where are they now?".
  10. ^ Health, Center for Devices and Radiological (2021-10-18). "September 2021 510(K) Clearances". FDA.
  11. ^ "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.
  12. ^ Behm, Carly (August 2022). "Dr. Anders Cohen debuts Kleiner Device Labs interbody system". www.beckersspine.com. Retrieved 2022-08-26.
  13. ^ Vetalice, Julie A. (August 1, 2022). "First Case with Kleiner Device Labs' KG2 Surge Flow-Thru Interbody". Orthoworld. Retrieved August 26, 2022.
  14. ^ "510(k) Premarket Notification". www.accessdata.fda.gov. Retrieved 2022-08-26.
  15. ^ "Kleiner introduces new spinal bone graft delivery tool". NS Medical Devices. 2018-01-11. Retrieved 2022-08-26.
  16. ^ "Research". www.healthpointcapital.com. Retrieved 2022-08-26.

Category:Business