Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Silony Medical GmbH — Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

150 daysmedian FDA review time
253 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH2026-06-262000
K254148VERTICALE GPS InstrumentsSilony Medical GmbH2026-02-19590
K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH2023-07-061990
K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH2022-12-22160
K212007VERTICALE Navigation InstrumentsSilony Medical GmbH2021-08-12450
K192013VERTICALE® Cervical SystemSilony Medical GmbH2020-04-072530
K190680FAVO S-TLIFSilony Medical GmbH2019-07-181220
K182608Oyster ACIF CageSilony Medical GmbH2019-06-132650
K181899ROCCIA® PLIFSilony Medical GmbH2018-12-131500
K180963ROCCIA ALIF, ROCCIA TLIFSilony Medical GmbH2018-07-11900
K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SysteSilony Medical GmbH2018-01-102400
K171434ROCCIA® MultiLIFSilony Medical GmbH2017-12-212200
K162587ROCCIA® ACIFSilony Medical GmbH2017-01-261320

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