CureOs TCP— 510(k) K191670
Substantially EquivalentLinacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic
FDA 510(k) clearance K191670 for CureOs TCP, Substantially Equivalent on 2020-08-04. Applicant: Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic. Device class: 2.
Clearance details
- Applicant
- Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic
- Product code
- Code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ankara, TR
Recent devices under product code MQV
view all- K260364 — Device 300419 Strip
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- K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip +7 more
- K253524 — Adaptos®Fuse Bone Graft
- K253147 — FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute
Adverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
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.