Data / Medical devices / United States / Kyocera Medical Technologies, Inc.
Kyocera Medical Technologies, Inc.: FDA-registered device maker in Redlands, CA, United States, 37 510(k) clearances
Kyocera Medical Technologies, Inc. is registered with the FDA (registration 3015398319) in Redlands, CA, United States. It lists 21 device types. The FDA files 37 510(k) clearances under its listings, the newest dated April 10, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015398319
- FEI number
- 3007932279
- Address
- 1289 Bryn Mawr Ave Ste A, Redlands, CA, United States, 92374
- Owner or operator
- Kyocera Medical Technologies, Inc. (10030880)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 23, 2009
- Registered through
- 2026
- Brand names listed
- A 200 Knee System, A 200 PS Knee System, Initia T3 Acetabular Hemispherical Shell System, KMTI S141 Lumbar Interbody Fusion System, KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System, Kyocera Bipolar Hip System, Kyocera Medical Technologies, Inc., PEEK SA Anterior Lumbar Interbody Fusion (ALIF) 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 |
|---|---|---|---|---|---|---|
| April 10, 2025 | K250486 | Skyway Anterior Cervical Plate System | KWQ | Substantially Equivalent | Kyocera Medical Technologies Inc. (KMTI) | accessdata.fda.gov |
| April 10, 2025 | K242045 | Initia T3 Acetabular Hemispherical Shell System | LPH | Substantially Equivalent | Kyocera Medical Technologies, Inc. | accessdata.fda.gov |
| March 20, 2025 | K242771 | Tesera-k PL System and Tesera-k XL System | MAX | Substantially Equivalent | Kyocera Medical Technologies, Inc. | accessdata.fda.gov |
| November 5, 2024 | K243015 | Skyway Anterior Cervical Plate System | KWQ | Substantially Equivalent | Kyocera Medical Technologies, Inc. | accessdata.fda.gov |
| April 4, 2024 | K232114 | TRIBRID® Unicompartmental Knee System | HSX | Substantially Equivalent | Kyocera Medical Technologies, Inc. | accessdata.fda.gov |
| September 12, 2023 | K231766 | Skyway Anterior Cervical Plate System | KWQ | Substantially Equivalent | Kyocera Medical Technologies Inc. (KMTI) | accessdata.fda.gov |
| April 21, 2023 | K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System | OVD | Substantially Equivalent | Kyocera Medical Technologies, Inc. | accessdata.fda.gov |
| December 22, 2022 | K223105 | Tesera-K SC System | OVE | Substantially Equivalent | Kyocera Medical Technologies, Inc. | accessdata.fda.gov |
| January 7, 2022 | K212980 | Tesera-k ALIF System | OVD | Substantially Equivalent | Kyocera Medical Technologies, Inc. | accessdata.fda.gov |
| August 30, 2021 | K212070 | KMTI S141 Lumbar Interbody Fusion System | MAX | Substantially Equivalent | Kyocera Medical Technologies, Inc. | accessdata.fda.gov |
| April 17, 2020 | K200709 | Kyocera Bipolar Hip System | KWY | Substantially Equivalent | Kyocera Medical Technologies, Inc. | accessdata.fda.gov |
| March 11, 2020 | K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | OQG | Substantially Equivalent | Kyocera Medical Technologies, Inc. | accessdata.fda.gov |
| February 4, 2020 | K193320 | KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System | OVD | Substantially Equivalent | Kyocera Medical Technologies, Inc. | accessdata.fda.gov |
| June 20, 2019 | K190122 | Renovis A200 PS Knee System as part of the Renovis A200 Knee System | JWH | Substantially Equivalent | Renovis Surgical Technologies | accessdata.fda.gov |
| December 7, 2018 | K182007 | Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System | OVD | Substantially Equivalent | Renovis Surgical Technologies | accessdata.fda.gov |
| September 11, 2018 | K181655 | Renovis S180 Lateral Lumbar Interbody Fusion System | MAX | Substantially Equivalent | Renovis Surgical Technologies | accessdata.fda.gov |
| June 14, 2018 | K180502 | S128 Anterior Lumbar Interbody Fusion (ALIF) System | OVD | Substantially Equivalent | Renovis Surgical Technologies, Inc. | accessdata.fda.gov |
| November 16, 2017 | K171543 | Renovis Surgical Hip Replacement System | OQG | Substantially Equivalent | Renovis Surgical Technologies | accessdata.fda.gov |
| August 8, 2017 | K170888 | Renovis S141 Lumbar Interbody Fusion System | MAX | Substantially Equivalent | Renovis Surgical Technologies | accessdata.fda.gov |
| March 16, 2016 | K153250 | Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System | OVE | Substantially Equivalent | Renovis Surgical Technologies | accessdata.fda.gov |
| September 25, 2015 | K152193 | Renovis Anterior Cervical Plate System | KWQ | Substantially Equivalent | Renovis Surgical Technologies, Inc. | accessdata.fda.gov |
| May 11, 2015 | K143647 | Renovis Surgical Hip Replacement System | OQG | Substantially Equivalent | Renovis Surgical Technologies, Inc. | accessdata.fda.gov |
| February 6, 2015 | K143126 | Renovis S141 Lumbar Interbody Cage System | MAX | Substantially Equivalent | Renovis Surgical Technologies | accessdata.fda.gov |
| November 4, 2014 | K141676 | RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM | LPH | Substantially Equivalent | Renovis Surgical Technologies, Inc. | accessdata.fda.gov |
| October 15, 2014 | K142095 | RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | OVD | Substantially Equivalent | Renovis Surgical Technologies, Inc. | accessdata.fda.gov |
| September 2, 2014 | K141370 | RENOVIS CEMENTED HIP SYSTEM | JDI | Substantially Equivalent | Renovis Surgical Technologies, Inc. | accessdata.fda.gov |
| April 11, 2014 | K132312 | RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM | LPH | Substantially Equivalent | Renovis Surgical Technologies, LLC | accessdata.fda.gov |
| March 27, 2014 | K140106 | S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | OVD | Substantially Equivalent | Renovis Surgical Technologies, Inc. | accessdata.fda.gov |
| September 19, 2013 | K131354 | RENOVIS BIPOLAR HIP SYSTEM | KWY | Substantially Equivalent | Renovis Surgical Technologies, LLC | accessdata.fda.gov |
| September 18, 2013 | K131122 | S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | OVD | Substantially Equivalent | Renovis Surgical Technologies, LLC | accessdata.fda.gov |
| February 14, 2013 | K120038 | A200 KNEE SYSTEM | OIY | Substantially Equivalent | Renovis Surgical Technologies, LLC | accessdata.fda.gov |
| June 13, 2012 | K112897 | RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS | OQG | Substantially Equivalent | Renovis Surgical Technologies, LLC | accessdata.fda.gov |
| May 15, 2012 | K111940 | S 100 PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | Renovis Surgical Technologies, LLC | accessdata.fda.gov |
| December 9, 2011 | K113084 | RENOVIS CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | Renovis Surgical Technologies, LLC | accessdata.fda.gov |
| May 11, 2011 | K110965 | RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | Renovis Surgical Technologies, LLC | accessdata.fda.gov |
| December 7, 2010 | K101682 | S 100 PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent | Renovis Surgical Technologies, LLC | accessdata.fda.gov |
| October 2, 2009 | K092082 | SYNERGY CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | Synergy Surgical Technologies, LLC | accessdata.fda.gov |
Compare with other makers
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- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Updated April 10, 2025. 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.