Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of KyoceraLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Kyocera Medical Technologies, Inc. with 19 510(k) clearances. The most recent is a 510(k) clearance dated Jul 15, 2026: Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anch….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 15, 2026 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemK261353 · OVD | 510(k) clearances |
| May 15, 2026 | Varion Thoracolumbar Fixation SystemK260989 · NKB | 510(k) clearances |
| Apr 10, 2025 | Initia T3 Acetabular Hemispherical Shell SystemK242045 · LPH | 510(k) clearances |
| Apr 10, 2025 | Tesera-k SC SystemK242928 · OVE | 510(k) clearances |
| Apr 10, 2025 | Skyway Anterior Cervical Plate SystemK250486 · KWQ | 510(k) clearances |
| Mar 20, 2025 | Tesera-k PL System and Tesera-k XL SystemK242771 · MAX | 510(k) clearances |
| Jan 13, 2025 | Initia Knee SystemK243295 · JWH | 510(k) clearances |
| Nov 5, 2024 | Skyway Anterior Cervical Plate SystemK243015 · KWQ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
