510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Silony Medical GmbH

Leinfelden-Echterdingen Baden-Wurttemberg, DE

SILONY MEDICAL GMBH appears in FDA device records in Leinfelden-Echterdingen Baden-Wurttemberg, DE. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
13
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 13 510(k) clearances for Silony Medical GmbH between 2017 and 2026. The busiest year on record is 2018, with 3. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Silony Medical GmbH, by decision year
YearClearances
20172
20183
20192
20201
20211
20221
20231
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253921VERTICALE® Navigation InstrumentsOLOSubstantially Equivalent
K254148VERTICALE GPS InstrumentsOLOSubstantially Equivalent
K223806VERTICALE® Triangular Fixation SystemNKBSubstantially Equivalent
K223649VERTICALE® Navigation InstrumentsOLOSubstantially Equivalent
K212007VERTICALE Navigation InstrumentsOLOSubstantially Equivalent
K192013VERTICALE® Cervical SystemNKGSubstantially Equivalent
K190680FAVO S-TLIFMAXSubstantially Equivalent
K182608Oyster ACIF CageODPSubstantially Equivalent
K181899ROCCIA® PLIFMAXSubstantially Equivalent
K180963ROCCIA ALIF, ROCCIA TLIFMAXSubstantially Equivalent
K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemNKBSubstantially Equivalent
K171434ROCCIA® MultiLIFMAXSubstantially Equivalent
K162587ROCCIA® ACIFODPSubstantially Equivalent

Registered establishments

FDA registered establishments for Silony Medical GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30134222363013422236SILONY MEDICAL GMBHLeinfelder Strasse 60, Leinfelden-Echterdingen Baden-Wurttemberg 70771 DE2026and 10 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain