Data / Medical devices / United States / Xenix Medical
Xenix Medical: FDA-registered device maker in Orlando, FL, United States, 9 510(k) clearances
Xenix Medical is registered with the FDA (registration 3012429289) in Orlando, FL, United States. It lists 20 device types. The FDA files 9 510(k) clearances under its listings, the newest dated September 14, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012429289
- Address
- 149 W Michigan St, Orlando, FL, United States, 32806
- Owner or operator
- Xenix Medical (10051846)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- July 14, 2017
- Registered through
- 2026
- Brand names listed
- Base Assembly Lateral SI Instrument Set Base, Graft Luer Caddy Base Lateral SI Instrument Caddy Base, Graft Luer Caddy Lid Lateral SI Instrument Caddy Lid, Handle, Stealth Palm, Ratchet, TQ Limit Grey, 14 IN-LBS, LUX Expandable Base Tray, LUX Expandable Instrument Insert, LUX Expandable Interbody System Wrench, LUX Expandable Lumbar Interbody System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Fixation, Spinal Intervertebral Body | LYQ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bender | HXW | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
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, 2026 | K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology | NKB | Substantially Equivalent | Xenix Medical | accessdata.fda.gov |
| February 23, 2026 | K253583 | LUX Expandable Lumbar Interbody System | MAX | Substantially Equivalent | Xenix Medical | accessdata.fda.gov |
| June 12, 2025 | K251154 | RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments | NKB | Substantially Equivalent | Ht Medical D.B.A. Xenix Medical | accessdata.fda.gov |
| October 27, 2023 | K233241 | SOLACE Sacroiliac Fixation System | OUR | Substantially Equivalent | Ht Medical, LLC Dba Xenix Medical | accessdata.fda.gov |
| September 1, 2023 | K222988 | neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical | ODP | Substantially Equivalent | Ht Medical D.B.A. Xenix Medical | accessdata.fda.gov |
| August 15, 2023 | K231829 | Xenix Medical Sacroiliac Fixation System | OUR | Substantially Equivalent | Ht Medical D.B.A. Xenix Medical | accessdata.fda.gov |
| January 7, 2019 | K182210 | TiWAVE-L Porous Titanium Lumbar Cage | MAX | Substantially Equivalent | Kalitec Medical, LLC | accessdata.fda.gov |
| June 14, 2018 | K180401 | TiWAVE-C Porous Titanium Cervical Cage | ODP | Substantially Equivalent | Kalitec Direct, LLC | accessdata.fda.gov |
| July 12, 2017 | K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical Interbody | ODP | Substantially Equivalent | Ht Medical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Wrench
- All makers of Reamer
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Bender
- All makers of Sacroiliac Joint Fixation
Updated September 14, 2026. 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.