Draft:Kleiner Device Labs
Submission declined on 5 September 2022 by Justlettersandnumbers (talk).
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| Submission declined on 27 August 2022 by Praxidicae (talk). This submission is not adequately supported by reliable sources. Reliable sources are required so that information can be verified. If you need help with referencing, please see Referencing for beginners and Citing sources. This draft's references do not show that the subject qualifies for a Wikipedia article. In summary, the draft needs multiple published sources that are: Declined by Praxidicae 2 years ago.
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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)
- Comment: This page has been moved back from article space to draft space. Please read the comments by the draftifying reviewer and address them. Do not resubmit this draft without addressing the comments of the previous reviewer. If you do not understand why this article was sent back to draft space, please ask the reviewer rather than simply resubmitting. You may ask for advice on how to improve this draft at the Teahouse or on the talk pages of any of the reviewers. (The declining reviewers may advise you to ask for advice at the Teahouse.)If this draft is resubmitted without any improvement or with very little improvement, it will probably be rejected. Robert McClenon (talk) 05:49, 26 August 2022 (UTC)
| 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[citation needed] |
| Fields | Medtech[3] |
Key people | Jeffrey B. Kleiner, MD (CEO), Alan Burkholder (CTO) |
| Award(s) | 2022 Medical Design Excellence Awards (Implant and Tissue-Replacement Products category)[4][5] |
| 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.[6] The company was founded in 2013 by Stanford graduate and spine surgeon Jeffrey B. Kleiner, MD (after 25+ years of active surgical practice).[citation needed] The organization maintains a portfolio of 23 patents for its technologies.[citation needed][7]
FDA 510(k) cleared products
[edit]- KG2 System - FDA cleared on September 14, 2021.[8] First use in patient on July 19, 2022.[9][10][11]
- KG1 Bi-Portal Bone Graft Delivery Device - FDA cleared on December 11, 2014.[12] Commercially available January 11, 2018.[13][14]
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.
- ^ 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. 5 April 2022.
- ^ Condon, Alan (25 February 2022). "23 spine device companies to watch in 2022". www.beckersspine.com. 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 (August 2022). "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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