Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medos International SARL — Predicate Candidate Screening
101 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
182 days90th percentile
101clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation | Medos International SARL | 2026-05-26 | 155 | 0 |
| K260240 | SYMPHONY Navigation Ready Instruments | Medos International SARL | 2026-03-27 | 60 | 0 |
| K253249 | TriALTIS™ Spine System | Medos International SARL | 2025-10-21 | 22 | 0 |
| K243249 | TriALTIS™ Spine System | Medos International SARL | 2025-01-17 | 98 | 0 |
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation | Medos International SARL | 2024-09-16 | 80 | 0 |
| K242042 | TriALTIS™ Spine System | Medos International SARL | 2024-09-09 | 59 | 0 |
| K233684 | TriALTIS™ Spine System | Medos International SARL | 2023-12-12 | 26 | 0 |
| K233366 | SYMPHONY OCT System | Medos International SARL | 2023-11-09 | 38 | 0 |
| K232492 | 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ F | Medos International SARL | 2023-10-06 | 50 | 0 |
| K231527 | TriALTIS Navigation Enabled Instruments | Medos International Sàrl | 2023-09-29 | 126 | 0 |
| K231479 | TriALTIS Spine System | Medos International SARL | 2023-09-22 | 123 | 0 |
| K223688 | CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ | Medos International Sàrl | 2023-03-08 | 89 | 0 |
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indication | Medos International SARL | 2023-02-10 | 88 | 0 |
| K223108 | TELIGEN System Navigation Ready Indications (TELIGEN Access | Medos International SARL | 2023-01-19 | 111 | 0 |
| K213978 | TELIGEN System | Medos International SARL | 2022-10-18 | 302 | 0 |
| K222473 | EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALY | Medos-International Sarl | 2022-10-13 | 58 | 0 |
| K221325 | CONDUIT Lateral Switch Plate | Medos International SARL | 2022-08-25 | 111 | 0 |
| K220040 | CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heli | Medos International SARL | 2022-07-14 | 190 | 1 |
| K221364 | Mitek TIGHT-N Anchor | Medos International SARL | 2022-07-11 | 61 | 0 |
| K212756 | Discectomy Navigation Ready Instruments and Universal Naviga | Medos International SARL | 2022-05-05 | 247 | 0 |
| K220219 | PERMALOOP Suture, PERMATAPE Suture | Medos International SARL | 2022-04-26 | 90 | 0 |
| K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | Medos International SARL | 2022-04-12 | 111 | 0 |
| K220374 | EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrate | Medos International SARL | 2022-03-08 | 27 | 0 |
| K210838 | PROWLER SELECT PLUS; PROWLER EX | Medos International SARL | 2021-08-25 | 156 | 0 |
| K211344 | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT | Medos International SARL | 2021-05-28 | 25 | 0 |
| K210728 | CONDUIT Instruments | Medos International SARL | 2021-05-06 | 56 | 0 |
| K203186 | DYNATAPE Suture | Medos International SARL | 2021-03-18 | 142 | 0 |
| K203319 | SYMPHONY™ OCT System | Medos International SARL | 2021-02-05 | 85 | 0 |
| K203794 | HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture | Medos International SARL | 2021-02-01 | 35 | 0 |
| K201661 | Symphony Navigation Ready Instruments and Universal Navigati | Medos International SARL | 2020-09-16 | 90 | 0 |
| K201883 | 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance | Medos International SARL | 2020-08-07 | 30 | 0 |
| K200791 | Navigation Enabled Intruments | Medos International SARL | 2020-07-31 | 127 | 0 |
| K200949 | HEALIX ADVANCE Anchor with DYNATAPE Suture | Medos International SARL | 2020-06-04 | 56 | 0 |
| K200245 | EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System | Medos International Sàrl | 2020-04-24 | 84 | 0 |
| K192646 | SYMPHONY™ OCT System | Medos International SARL | 2020-04-02 | 191 | 0 |
| K192804 | CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90 | Medos International SARL | 2020-02-27 | 149 | 1 |
| K192014 | SYPMHONY™ OCT System | Medos International SARL | 2020-01-24 | 179 | 0 |
| K190284 | Bengal Stackable Cage System | Medos International SARL | 2019-12-20 | 312 | 0 |
| K192281 | AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation S | Medos International SARL | 2019-11-20 | 90 | 0 |
| K191943 | SYMPHONY Navigation Ready Instruments, Universal Navigation | Medos International SARL | 2019-10-18 | 88 | 0 |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw | Medos International SARL | 2019-09-24 | 141 | 0 |
| K191242 | HEALIX ADVANCE SP BIOCOMPOSITE Anchor | Medos International SARL | 2019-08-22 | 105 | 0 |
| K190774 | RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation Syst | Medos International SARL | 2019-07-25 | 121 | 0 |
| K190895 | MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation | Medos International SARL | 2019-07-18 | 104 | 0 |
| K191483 | HEALIX ADVANCE Anchor with DYNA+TAPE Sutures | Medos International SARL | 2019-06-28 | 24 | 0 |
| K182349 | CONCORDE LIFT | Medos International SARL | 2019-04-03 | 217 | 0 |
| K182941 | HEALIX ADVANCE SP PEEK Anchor | Medos International SARL | 2019-02-26 | 126 | 0 |
| K183279 | HEALIX Ti ANCHOR with DYNACORD | Medos International SARL | 2019-02-21 | 90 | 0 |
| K183506 | HEALIX ADVANCE Anchor with DYNACORD Suture | Medos International SARL | 2019-02-14 | 58 | 0 |
| K181949 | SYMPHONY™ OCT System | Medos International SARL | 2018-10-04 | 76 | 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