Data / Medical devices / United States / Spinevision Inc.
Spinevision Inc.: FDA-registered device maker in Farmers Branch, TX, United States, 21 510(k) clearances
Spinevision Inc. is registered with the FDA (registration 3025457095) in Farmers Branch, TX, United States. It lists 33 device types. The FDA files 21 510(k) clearances under its listings, the newest dated December 16, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025457095
- Address
- 3321 Towerwood Dr Ste 130, Farmers Branch, TX, United States, 75234
- Owner or operator
- SPINEVISION SAS (9048013)
- Roles
- Complaint file establishment
- First device listed
- February 21, 2002
- Registered through
- 2026
- Brand names listed
- AC2-CSL05C, AC2-CSL05C_Convex Ti SA Cervical Cage, AC2-CSL05L, AC2-CSL05L_Lordotic Ti SA Cervical Cage, AC2-CSL06C, AC2-CSL06C_Convex Ti SA Cervical Cage, AC2-CSL06L, AC2-CSL06L_Lordotic Ti SA Cervical Cage 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 |
|---|---|---|---|---|---|---|
| December 16, 2022 | K223251 | Hexanium PLIF | MAX | Substantially Equivalent | Spinevision, S.A.S. | accessdata.fda.gov |
| November 14, 2022 | K221578 | Hexanium ACIF | OVE | Substantially Equivalent | Spinevision, S.A.S. | accessdata.fda.gov |
| March 10, 2021 | K210359 | Hexanium TLIF | MAX | Substantially Equivalent | Spinevision, S.A.S. | accessdata.fda.gov |
| October 20, 2020 | K193000 | Hexanium® ACIF | OVE | Substantially Equivalent | Spinevision, S.A.S. | accessdata.fda.gov |
| May 4, 2018 | K180437 | Hexanium® TLIF | MAX | Substantially Equivalent | Spinevision, S.A.S. | accessdata.fda.gov |
| May 4, 2016 | K153783 | SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF | MAX | Substantially Equivalent | Spinevision S.A. | accessdata.fda.gov |
| April 4, 2016 | K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System | MNI | Substantially Equivalent | Spinevision S.A. | accessdata.fda.gov |
| June 30, 2014 | K133575 | SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM | MNH | Substantially Equivalent | Spinevision S.A. | accessdata.fda.gov |
| July 30, 2013 | K130302 | SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT | MNI | Substantially Equivalent | Spinevision S.A. | accessdata.fda.gov |
| June 7, 2012 | K112607 | SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ... | NKB | Substantially Equivalent | Spinevision S.A. | accessdata.fda.gov |
| November 7, 2005 | K052406 | UNI-THREAD SPINAL SYSTEM | MNI | Substantially Equivalent | Spine Vision, Inc. | accessdata.fda.gov |
| December 28, 2004 | K042930 | SPACEVISION CAGE SYSTEM | MQP | Substantially Equivalent | Spine Vision, Inc. | accessdata.fda.gov |
| November 23, 2004 | K042640 | UNI-THREAD SPINAL SYSTEM | MNH | Substantially Equivalent | Spine Vision, Inc. | accessdata.fda.gov |
| January 27, 2004 | K033508 | PLUS PIVOT LINK UNIVERSAL SYSTEM | MNI | Substantially Equivalent | Spine Vision, Inc. | accessdata.fda.gov |
| October 31, 2003 | K032398 | PLUS PIVOT LINK UNIVERSAL SYSTEM | MNI | Substantially Equivalent | Spine Vision, Inc. | accessdata.fda.gov |
| September 23, 2002 | K022271 | PLUS PIVOT LINK UNIVERSAL SYSTEM | MNI | Substantially Equivalent | Spine Vision, Inc. | accessdata.fda.gov |
| August 1, 2002 | K021510 | UNI-T UNI-THREAD SPINAL SYSTEM | MNI | Substantially Equivalent | Spine Vision, Inc. | accessdata.fda.gov |
| August 1, 2002 | K021507 | PLUS PIVOT LINK UNIVERSAL SYSTEM | KWP | Substantially Equivalent | Spine Vision, Inc. | accessdata.fda.gov |
| February 13, 2002 | K013312 | P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM) | KWP | Substantially Equivalent | Spine Vision, Inc. | accessdata.fda.gov |
| February 13, 2002 | K013301 | UNI-T SPINAL SYSTEM | MNI | Substantially Equivalent | Spine Vision, Inc. | accessdata.fda.gov |
| November 26, 2001 | K012881 | C3 ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Spine Vision, Inc. | accessdata.fda.gov |
Compare with other makers
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Updated December 16, 2022. 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.