Data / Medical devices / United States / Kalitec Direct LLC DBA Kalitec Medical
Kalitec Direct LLC DBA Kalitec Medical: FDA-registered device maker in Sarasota, FL, United States, 10 510(k) clearances
Kalitec Direct LLC DBA Kalitec Medical is registered with the FDA (registration 3009165919) in Sarasota, FL, United States. It lists 41 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009165919
- Address
- 1819 Main St Ste 303, Sarasota, FL, United States, 34236
- Owner or operator
- Kalitec Medical (10037099)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- August 1, 2011
- Registered through
- 2026
- Brand names listed
- Awl Tap, Fixed Sleeve, CosmoLock Pedicle Screw System, InSePtion MIS Fixation System, Inseption MIS Fixation System, Kalitec Disc Prep 3 mm Straight Pituitary, Kalitec Disc Prep 3 mm Up Biting Pituitary, Kalitec Navigated Instrument System, Matira Anterior Cervical System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Awl | HWJ | 1 | 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 |
| Bit, Drill | HTW | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Caliper | KTZ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette | HTF | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 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 |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Repackager or relabeler, 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, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | 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 |
| Punch, Surgical | LRY | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rasp | HTR | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retainer, Surgical | GCZ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spinous Process Plate | PEK | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Starter, Bone Screw | HWD | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tamp | HXG | 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 |
|---|---|---|---|---|---|---|
| December 13, 2023 | K232572 | Kalitec Navigated Instrument System | OLO | Substantially Equivalent | Kalitec Direct, LLC Doing Business AS Kalitec Medical | accessdata.fda.gov |
| September 15, 2023 | K230974 | NIDO Pedicle Screw System | NKB | Substantially Equivalent | Kalitec Medical | accessdata.fda.gov |
| May 27, 2022 | K220902 | Navagio Lumbar Cage | MAX | Substantially Equivalent | Kalitec Medical, LLC | accessdata.fda.gov |
| October 25, 2017 | K172808 | CosmoLock Pedicle Screw System | NKB | Substantially Equivalent | Kalitec Direct, LLC | accessdata.fda.gov |
| September 22, 2017 | K172086 | Matira Anterior Cervical System | KWQ | Substantially Equivalent | Kalitec Direct, LLC | accessdata.fda.gov |
| May 9, 2017 | K170342 | Ocata Anterior Cervical System | KWQ | Substantially Equivalent | Kalitec Direct, LLC | accessdata.fda.gov |
| March 16, 2017 | K163471 | Kalitec Direct InSePtion MIS Fixation System | PEK | Substantially Equivalent | Kalitec Direct, LLC | accessdata.fda.gov |
| June 19, 2014 | K140678 | COSMOLOCK PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | Kalitec Direct, LLC | accessdata.fda.gov |
| April 16, 2014 | K133815 | INTESS CERVICAL CAGE SYSTEM | ODP | Substantially Equivalent | Kalitec Direct, LLC | accessdata.fda.gov |
| March 28, 2013 | K123100 | INTESS LUMBAR CAGE | MAX | Substantially Equivalent | Kalitec Direct, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Awl
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Retainer, Surgical
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Curette
Updated December 13, 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.