NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY— 510(k) K102722
Substantially EquivalentSynthes USA Products, LLC
FDA 510(k) clearance K102722 for NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY, Substantially Equivalent on 2011-01-27. Applicant: Synthes USA Products, LLC. Device class: 2.
Clearance details
- Applicant
- Synthes USA Products, LLC
- 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
- West Chester, PA, US
Recent devices under product code MQV
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- K210205 — DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
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 →
Recalls naming K102722
K-number listed on FDA's recall record- Z-0617-2018 — Norian Drillable Inject
- Z-1942-2016 — Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure.
- Z-1943-2016 — Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
- Z-1944-2016 — Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102722.
Data sourced from openFDA. This site is unofficial and independent of the FDA.