NB3D BONE VOID FILLER— 510(k) K132050
Substantially EquivalentPioneer Surgical Technology, Inc.
FDA 510(k) clearance K132050 for NB3D BONE VOID FILLER, Substantially Equivalent on 2014-02-07. Applicant: Pioneer Surgical Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Pioneer Surgical Technology, 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
- Marquette, MI, US
Recent devices under product code MQV
view allMore clearances from Pioneer Surgical Technology, 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 K132050
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132050.
Data sourced from openFDA. This site is unofficial and independent of the FDA.