HydroSet XT— 510(k) K161447
Substantially EquivalentOrthovita, Inc.
FDA 510(k) clearance K161447 for HydroSet XT, Substantially Equivalent on 2016-10-06. Applicant: Orthovita, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthovita, Inc.
- 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
- Malver, PA, US
Recent devices under product code MQV
view allMore clearances from Orthovita, Inc.
view allAdverse 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 →
Recalls naming K161447
K-number listed on FDA's recall record- Z-0677-2019 — HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
- Z-0678-2019 — HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161447.
Data sourced from openFDA. This site is unofficial and independent of the FDA.