QWIX POSITIONING SCREW— 510(k) K071639
Substantially EquivalentNewdeal Sas
FDA 510(k) clearance K071639 for QWIX POSITIONING SCREW, Substantially Equivalent on 2007-07-09. Applicant: Newdeal Sas. Device class: 2.
Clearance details
- Applicant
- Newdeal Sas
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Planisboro, NJ, US
Recent devices under product code HWC
view allMore clearances from Newdeal Sas
view allAdverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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 K071639
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 K071639.
Data sourced from openFDA. This site is unofficial and independent of the FDA.