Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Mikron Makina Sanayi VE Ticaret Ltd. Sti. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241657 | MSFX MIKRON SPINAL FIXATION SYSTEM | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024-09-30 | 112 | 0 |
| K240484 | MSFX Mikron Cervical Anterior Plate System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024-04-17 | 57 | 0 |
| K130073 | MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2013-12-16 | 339 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda