NORIAN DRILLABLE— 510(k) K073303
UnknownSynthes (Usa)
FDA 510(k) clearance K073303 for NORIAN DRILLABLE, Unknown on 2008-07-02. Applicant: Synthes (Usa). Device class: 2.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code OIS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- West Chester, PA, US
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- K120717 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
Recalls naming K073303
K-number listed on FDA's recall record- Z-0618-2018 — Norian Drillable Inject
- 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 K073303.
Data sourced from openFDA. This site is unofficial and independent of the FDA.