PLLA, HA SCREW— 510(k) K080358
Substantially EquivalentSmith & Nephew Inc., Endoscopy Div.
FDA 510(k) clearance K080358 for PLLA, HA SCREW, Substantially Equivalent on 2008-04-23. Applicant: Smith & Nephew Inc., Endoscopy Div.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew Inc., Endoscopy Div.
- 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
- Traditional
- Location
- Andover, MA, US
Recent devices under product code HWC
view allMore clearances from Smith & Nephew Inc., Endoscopy Div.
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 K080358
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 K080358.
Data sourced from openFDA. This site is unofficial and independent of the FDA.