Icotec Ag
FDA Regulatory Profile
Icotec Ag appears in FDA public data with 3 recalls, 17 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0700-2024, Class II) was initiated on November 28, 2023. Its most recent 510(k) clearance was granted on November 12, 2025.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 17
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0700-2024 | Class II | VADER pedicle system, torque wrench, Catalog Number 42-702 | November 28, 2023 |
| Z-0701-2024 | Class II | VADER pedicle system, torque wrench, Catalog Number 42-703 | November 28, 2023 |
| Z-0728-2023 | Class II | VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 | November 3, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | November 12, 2025 |
| K242900 | VADER® Pedicle System and VADER®one Pedicle System | February 27, 2025 |
| K233215 | icotec Anterior Cervical Plate System | May 17, 2024 |
| K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumb | April 5, 2024 |
| K232790 | KONG®-TL VBR System and KONG® C VBR System | April 4, 2024 |
| K232628 | VADER® Pedicle System | February 26, 2024 |
| K230861 | VADER® Pedicle System Navigated Instruments | June 27, 2023 |
| K222789 | VADER® Pedicle System, G21 Cement | January 9, 2023 |
| K201587 | icotec Anterior Cervical Plate System | October 15, 2020 |
| K200596 | G21 Cement, VADER® Pedicle System | October 13, 2020 |
| K200235 | KONG-TL VBR System, KONG-C VBR System | May 29, 2020 |
| K193423 | VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 | May 22, 2020 |
| K192897 | icotec Cervical Cage | March 20, 2020 |
| K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | June 20, 2019 |
| K172480 | icotec Interbody Cage System | May 17, 2018 |
| K151977 | icotec Pedicle System | April 12, 2016 |
| K100305 | ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K | July 21, 2011 |