Chrysalis Intelligence · Sponsors · Medos International SARL

Medos International SARL

Lelocle, CH · 33 510(k) clearances · 1 recalls (1 Class I)

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Total clearances
33
2020-01-24 → 2026-05-26
Last 12 months
3
Product codes
11
Most recent
2026-05-26
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OLO Orthopedic Stereotaxic Instrument Class II Neurology 7 2026-05-26
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 6 2025-10-21
MBI Fastener, Fixation, Nondegradable, Soft Tissue Class II Orthopedic 5 2023-10-06
NKG Posterior Cervical Screw System Class II Orthopedic 4 2023-11-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Class II Orthopedic 2 2022-08-25
HCG — — — 2 2022-07-14
GAT Suture, Nonabsorbable, Synthetic, Polyethylene Class II General, Plastic Surgery 2 2022-04-26
KRA — — — 2 2022-04-12
PDQ Neurosurgical Nerve Locator Class II Ear, Nose, Throat 1 2023-02-10
HRX Arthroscope Class II Orthopedic 1 2022-10-18
QJP — — — 1 2020-02-27
Safety

Recalls (1)

Class I (serious)
1
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2024-02-02
DateSeverityStatusRecall # ProductCodeReason
2024-02-02 Class I Ongoing Z-1284-2024 CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-cathe… — Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural d…
Filings

All 510(k) clearances (33)

Date K-number Device Code Class Specialty
2026-05-26 K254157 CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody OLO Class II Neurology
2026-03-27 K260240 SYMPHONY Navigation Ready Instruments OLO Class II Neurology
2025-10-21 K253249 TriALTIS™ Spine System NKB Class II Orthopedic
2025-01-17 K243249 TriALTIS™ Spine System NKB Class II Orthopedic
2024-09-16 K241893 CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays OLO Class II Neurology
2024-09-09 K242042 TriALTIS™ Spine System NKB Class II Orthopedic
2023-12-12 K233684 TriALTIS™ Spine System NKB Class II Orthopedic
2023-11-09 K233366 SYMPHONY OCT System NKG Class II Orthopedic
2023-10-06 K232492 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor MBI Class II Orthopedic
2023-09-22 K231479 TriALTIS Spine System NKB Class II Orthopedic
2023-02-10 K223438 TELIGEN System Peripheral Motor Nerve Stimulation Indications PDQ Class II Ear, Nose, Throat
2023-01-19 K223108 TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) OLO Class II Neurology
2022-10-18 K213978 TELIGEN System HRX Class II Orthopedic
2022-08-25 K221325 CONDUIT Lateral Switch Plate MAX Class II Orthopedic
2022-07-14 K220040 CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems HCG — —
2022-07-11 K221364 Mitek TIGHT-N Anchor MBI Class II Orthopedic
2022-05-05 K212756 Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set OLO Class II Neurology
2022-04-26 K220219 PERMALOOP Suture, PERMATAPE Suture GAT Class II General, Plastic Surgery
2022-04-12 K214025 PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter KRA — —
2022-03-08 K220374 EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) NKB Class II Orthopedic
2021-08-25 K210838 PROWLER SELECT PLUS; PROWLER EX KRA — —
2021-05-28 K211344 MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems HCG — —
2021-05-06 K210728 CONDUIT Instruments MAX Class II Orthopedic
2021-03-18 K203186 DYNATAPE Suture GAT Class II General, Plastic Surgery
2021-02-05 K203319 SYMPHONY™ OCT System NKG Class II Orthopedic
2021-02-01 K203794 HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture MBI Class II Orthopedic
2020-09-16 K201661 Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set OLO Class II Neurology
2020-08-07 K201883 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor MBI Class II Orthopedic
2020-07-31 K200791 Navigation Enabled Intruments OLO Class II Neurology
2020-06-04 K200949 HEALIX ADVANCE Anchor with DYNATAPE Suture MBI Class II Orthopedic
2020-04-02 K192646 SYMPHONY™ OCT System NKG Class II Orthopedic
2020-02-27 K192804 CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm QJP — —
2020-01-24 K192014 SYPMHONY™ OCT System NKG Class II Orthopedic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence