KONG®-TL VBR System and KONG® C VBR System— 510(k) K232790
Substantially EquivalentIcotec AG
FDA 510(k) clearance K232790 for KONG®-TL VBR System and KONG® C VBR System, Substantially Equivalent on 2024-04-04. Applicant: Icotec AG. Device class: 2.
Clearance details
- Applicant
- Icotec AG
- Product code
- Code MQP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- 9450 Altstaetten (Sg), CH
Recent devices under product code MQP
view allMore clearances from Icotec AG
view all- K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments
- K242900 — VADER® Pedicle System and VADER®one Pedicle System
- K233215 — icotec Anterior Cervical Plate System
- K232792 — icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage)
- K232628 — VADER® Pedicle System
Adverse events under product code MQP
product code MQP- Injury
- 372
- Malfunction
- 519
- Total
- 891
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.