VERTICALE® Triangular Fixation System
Silony Medical GmbH
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012764194 | 3012764194 | Silony Medical International AG | 1 | N | 2026-01-01 | Leinfelder Strasse 60 Leinfelden Echterdingen Baden-Wurttemberg DE 70771 |
| 3013422236 | 3013422236 | SILONY MEDICAL GMBH | 1 | N | 2026-01-01 | Leinfelder Strasse 60 Leinfelden-Echterdingen Baden-Wurttemberg DE 70771 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 206063 | 1610390165 | K254148 | VERTICALE GPS Instruments | OLO | 2026-02-19 |
| 205542 | 1610390165 | K254148 | VERTICALE GPS Instruments | OLO | 2026-02-19 |
| 205542 | 1340525280 | K223649 | VERTICALE® Navigation Instruments | OLO | 2022-12-22 |
| 206063 | 1340525280 | K223649 | VERTICALE® Navigation Instruments | OLO | 2022-12-22 |
| 205542 | 1055742761 | K212007 | VERTICALE Navigation Instruments | OLO | 2021-08-12 |
| 206063 | 1055742761 | K212007 | VERTICALE Navigation Instruments | OLO | 2021-08-12 |
| 206063 | 1141102727 | K192013 | VERTICALE® Cervical System | NKG | 2020-04-07 |
| 205542 | 1141102727 | K192013 | VERTICALE® Cervical System | NKG | 2020-04-07 |
| 206063 | 1623859448 | K190680 | FAVO S-TLIF | MAX | 2019-07-18 |
| 205542 | 1623859448 | K190680 | FAVO S-TLIF | MAX | 2019-07-18 |
| 206063 | 1414537688 | K182608 | Oyster ACIF Cage | ODP | 2019-06-13 |
| 205542 | 1414537688 | K182608 | Oyster ACIF Cage | ODP | 2019-06-13 |
| 206063 | 1853378996 | K181899 | ROCCIA® PLIF | MAX | 2018-12-13 |
| 205542 | 1853378996 | K181899 | ROCCIA® PLIF | MAX | 2018-12-13 |
| 206063 | 1346181732 | K180963 | ROCCIA ALIF, ROCCIA TLIF | MAX | 2018-07-11 |
| 205542 | 1346181732 | K180963 | ROCCIA ALIF, ROCCIA TLIF | MAX | 2018-07-11 |
| 205542 | 1236504392 | K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX | MAX | 2018-05-08 |
| 206063 | 1236504392 | K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX | MAX | 2018-05-08 |
| 206063 | 1238432912 | K171434 | ROCCIA® MultiLIF | MAX | 2017-12-21 |
| 205542 | 1238432912 | K171434 | ROCCIA® MultiLIF | MAX | 2017-12-21 |
| 206063 | 1566754643 | K171421 | VERTICALE® Posterior Spinal Fixation System/VERTICALE® System | NKB | 2018-01-10 |
| 205542 | 1566754643 | K171421 | VERTICALE® Posterior Spinal Fixation System/VERTICALE® System | NKB | 2018-01-10 |
| 206063 | 2044788692 | K171112 | Trifore(tm) Cervical Plating System | KWQ | 2017-06-08 |
| 205542 | 2044788692 | K171112 | Trifore(tm) Cervical Plating System | KWQ | 2017-06-08 |
| 205542 | 1688861702 | K162587 | ROCCIA® ACIF | ODP | 2017-01-26 |
| 206063 | 1688861702 | K162587 | ROCCIA® ACIF | ODP | 2017-01-26 |
| 206063 | 1980222651 | K152211 | PCT System | NKG | 2015-12-01 |
| 205542 | 1980222651 | K152211 | PCT System | NKG | 2015-12-01 |
| 205542 | 1238423342 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | OVD | 2015-06-08 |
| 206063 | 1238423342 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | OVD | 2015-06-08 |
| 205542 | 1482571663 | K150053 | STALIF C; STALIF C-Ti | OVE | 2015-06-24 |
| 206063 | 1482571663 | K150053 | STALIF C; STALIF C-Ti | OVE | 2015-06-24 |
| 206063 | 1552928214 | K142079 | STALIF CTI, STALIF C | OVE | 2014-10-24 |
| 205542 | 1552928214 | K142079 | STALIF CTI, STALIF C | OVE | 2014-10-24 |
| 205542 | 1761582783 | K141942 | MIDLINE II TI | OVD | 2014-11-07 |
| 206063 | 1761582783 | K141942 | MIDLINE II TI | OVD | 2014-11-07 |
| 205542 | 1887013796 | K133286 | MIDLINE (TM) | OVD | 2014-01-09 |
| 206063 | 1887013796 | K133286 | MIDLINE (TM) | OVD | 2014-01-09 |
| 205542 | 1125730387 | K133200 | STALIF C(R) | OVE | 2014-05-08 |
| 206063 | 1125730387 | K133200 | STALIF C(R) | OVE | 2014-05-08 |
| 205542 | 2011108492 | K130461 | STALIF X | OVD | 2013-08-28 |
| 206063 | 2011108492 | K130461 | STALIF X | OVD | 2013-08-28 |
| 206063 | 1793718166 | K122444 | CERVICAL CAGE | ODP | 2012-08-30 |
| 205542 | 1793718166 | K122444 | CERVICAL CAGE | ODP | 2012-08-30 |
| 205542 | 1347361890 | K120819 | STALIF C | OVE | 2012-08-31 |
| 206063 | 1347361890 | K120819 | STALIF C | OVE | 2012-08-31 |
| 205542 | 1010287402 | K110915 | CERVICAL CAGE | ODP | 2011-07-22 |
| 206063 | 1010287402 | K110915 | CERVICAL CAGE | ODP | 2011-07-22 |
| 206063 | 1392692446 | K072415 | STALIF (TM) C | OVE | 2008-01-25 |
| 205542 | 1392692446 | K072415 | STALIF (TM) C | OVE | 2008-01-25 |
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| 206063 | 2016354749 | ||||
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Silony Medical GmbH
Silony Medical GmbH
Silony Medical GmbH
Silony Medical GmbH
Silony Medical GmbH
Silony Medical GmbH
Silony Medical GmbH
Silony Medical GmbH
Silony Medical GmbH
Silony Medical GmbH
SILONY MEDICAL GMBH
2025-11-24
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