Data / Medical devices / United States / Choice Spine LLC
Choice Spine LLC: FDA-registered device maker in Knoxville, TN, United States, 72 510(k) clearances
Choice Spine LLC is registered with the FDA (registration 3005819474) in Knoxville, TN, United States. It lists 20 device types. The FDA files 72 510(k) clearances under its listings, the newest dated September 14, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005819474
- Address
- 400 Erin Dr, Knoxville, TN, United States, 37919
- Owner or operator
- CHOICE SPINE, LLC (9090881)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 20, 2006
- Registered through
- 2027
- Brand names listed
- ALTES, Ambassador, Anterior Cervical Plate (ACP), Ascendant, Ascendant PC, Blackbird HLS (Hinged Laminoplasty System), Blackbird Spinal System, Blackhawk Cervical Spacer System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 14, 2023 | K223869 | ChoiceSpine Blackhawk Ti Cervical Spacer System | OVE | Substantially Equivalent | Choice Spine, LLC | accessdata.fda.gov |
| September 13, 2022 | K220953 | ChoiceSpine TigerShark M, Modular Interbody System | MAX | Substantially Equivalent | Choice Spine, LLC | accessdata.fda.gov |
| July 6, 2022 | K220024 | ChoiceSpine Navigation System | OLO | Substantially Equivalent | Choice Spine, LLC | accessdata.fda.gov |
| August 31, 2021 | K211449 | Triton Sacroiliac Joint Fixation System | OUR | Substantially Equivalent | Choice Spine, LLC | accessdata.fda.gov |
| May 10, 2021 | K203311 | ChoiceSpine Blackhawk Ti Cervical Spacer System | OVE | Substantially Equivalent | Choice Spine, LLC | accessdata.fda.gov |
| January 4, 2021 | K203561 | ChoiceSpine Navigation System | OLO | Substantially Equivalent | Choice Spine, LLC | accessdata.fda.gov |
| December 22, 2020 | K201643 | ChoiceSpine Tiger Shark Cervical Spacer System | ODP | Substantially Equivalent | Choice Spine, LLC | accessdata.fda.gov |
| July 5, 2019 | K191367 | Harrier-SA Lumbar Interbody System | MAX | Substantially Equivalent | Choice Spine, LLC | accessdata.fda.gov |
| May 1, 2019 | K190227 | Boomerang Anterior Cervical Plate System | KWQ | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| March 21, 2019 | K182074 | Mineral Collagen Composite Bioactive Moldable | MQV | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| March 6, 2019 | K183397 | ChoiceSpine Stealth Cervical Spacer System | ODP | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| February 22, 2019 | K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | MQP | Substantially Equivalent | Choicespine | accessdata.fda.gov |
| January 8, 2019 | K182721 | Choice Spine Navigation System | OLO | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| January 3, 2019 | K183214 | Raven Lumbar Plate System | KWQ | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| May 16, 2018 | K180519 | HARRIER-SA Lumbar Interbody System | OVD | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| January 26, 2018 | K172816 | TiGer Shark System | MAX | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| January 19, 2018 | K173215 | Choice Spine Laminoplasty Fixation System | NQW | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| September 15, 2017 | K171686 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | MQP | Substantially Equivalent | Choicespine | accessdata.fda.gov |
| August 3, 2017 | K171456 | Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems | NKB | Substantially Equivalent | Choicespine | accessdata.fda.gov |
| June 8, 2017 | K170821 | ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System | NKB | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| April 26, 2017 | K170942 | The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems | NKB | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| April 21, 2017 | K170953 | Tomcat Cervical Spinal System | OVE | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| November 23, 2016 | K162103 | Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye) | MAX | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| June 28, 2016 | K160697 | Gibralt® Spine System and Gibralt® Occipital Spine System | NKG | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| June 3, 2016 | K160775 | Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems | NKB | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| May 19, 2016 | K153107 | Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine VEO Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System | MAX | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| December 18, 2015 | K152515 | TOMCAT Cervical Spinal System | OVE | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| May 28, 2015 | K150130 | Ascendant TM Cervical Spacer System | ODP | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 11, 2015 | K150152 | The Octane Straight Intervertebral Fusion Device, Ti Coated | MAX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| February 27, 2015 | K143576 | Exactech Ambassador | KWQ | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| August 15, 2014 | K141129 | EXACTECH CERVICAL SPACER SYSTEM | ODP | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| August 15, 2014 | K132049 | THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS | NKB | Substantially Equivalent | Choicespine | accessdata.fda.gov |
| July 16, 2014 | K140142 | CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) | MAX | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| April 25, 2014 | K123607 | OCTANE ELEVATE SPINAL IMPLANT SYSTEM | MAX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| April 11, 2014 | K140645 | GIBRALT ROD-TO-ROD CROSS CONNECTORS | KWP | Substantially Equivalent | Exactech Sarasota | accessdata.fda.gov |
| March 7, 2014 | K133214 | BLACKBIRD SPINAL SYSTEM | KWP | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| February 12, 2014 | K132582 | EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM | OVE | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 1, 2013 | K130434 | OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC | MAX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| April 1, 2013 | K123997 | TRANS1LATERAL INTERBODY FUSION SYSTEM | MAX | Substantially Equivalent | Trans1, Inc. | accessdata.fda.gov |
| February 12, 2013 | K121877 | GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES | KWP | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| September 20, 2012 | K121850 | Typhoon(TM) Facet Screw Fixation System | MRW | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| April 5, 2012 | K120570 | CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM | MQP | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| November 21, 2011 | K112097 | GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 | MRW | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| July 15, 2011 | K110197 | EXACTECH GIBRALT SPINAL SYSTEM | MNI | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| January 21, 2011 | K102870 | EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| November 15, 2010 | K102204 | CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| August 26, 2010 | K100210 | TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T | MAX | Substantially Equivalent | Trans1 Incorporated | accessdata.fda.gov |
| December 22, 2009 | K091926 | CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM | KWQ | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| November 2, 2009 | K091531 | CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER | ODP | Substantially Equivalent | Choice Spine, Llp | accessdata.fda.gov |
| February 15, 2008 | K073245 | EXTENDED VERTIFLEX SPINAL SCREW SYSTEM | NKB | Substantially Equivalent | Vertiflex, Inc. | accessdata.fda.gov |
| February 13, 2008 | K073669 | ORIA NATURA SPACER | MAX | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| January 12, 2007 | K062670 | VERTIFLEX SPINAL SCREW SYSTEM | MNH | Substantially Equivalent | Vertiflex (Tm), Incorporated | accessdata.fda.gov |
| July 26, 2006 | K061482 | ALTES BUTTRESS PLATING SYSTEM | KWQ | Substantially Equivalent | Altiva Corp. | accessdata.fda.gov |
| March 12, 2004 | K040346 | MODIFICATION TO ORIA TOP CLIP SYSTEM | MNI | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| November 20, 2003 | K030958 | ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS | MNI | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| October 10, 2003 | K031471 | ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01 | KWP | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| August 20, 2003 | K023884 | MODIFICATION ORIA SPINAL SYSTEM | KWP | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| June 27, 2003 | K023378 | ORIA CLARIS | MNH | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| June 18, 2003 | K031452 | ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 | KWP | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| March 4, 2003 | K023377 | ORIA CERVICAL PLATES | KWQ | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| February 21, 2003 | K030253 | ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 | KWP | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| February 21, 2003 | K030252 | ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07) | KWP | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| February 5, 2003 | K023994 | ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ | MNH | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| November 19, 2002 | K021679 | ORIA SPINAL CLIP SYSTEM | KWP | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| July 3, 2002 | K021919 | SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO | KWP | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| May 31, 2002 | K021379 | SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 | MNI | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| August 7, 2001 | K011807 | SCS CLARIS SPINAL SCREWS, TYPES V,G,E | MNI | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| July 11, 2001 | K003823 | SCS DT-02 TRANSVERSE CONNECTOR | KWP | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| May 8, 2001 | K010369 | CLARIS PLATE SYSTEM | MNH | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| April 10, 2000 | K994288 | 5.0MM SPINAL SCREWS | MNH | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| December 17, 1999 | K993926 | OMNIAXIAL CONNECTOR | MNH | Substantially Equivalent | Ortho Tec, LLC | accessdata.fda.gov |
| December 18, 1998 | K983353 | SCS SPINAL SYSTEM | KWP | Substantially Equivalent | Orthotec, Inc. | accessdata.fda.gov |
Compare with other makers
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- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
- All makers of Screwdriver
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
Updated September 14, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.