Stryker Footed Attachments and Cutting Accessories— 510(k) K143399
Substantially EquivalentStryker Corp.
FDA 510(k) clearance K143399 for Stryker Footed Attachments and Cutting Accessories, Substantially Equivalent on 2015-05-08. Applicant: Stryker Corp.. Device class: 2.
Clearance details
- Applicant
- Stryker Corp.
- Product code
- Code HBE
- Device class
- Class 2
- Regulation
- 21 CFR 882.4310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portage, MI, US
Recent devices under product code HBE
view allMore clearances from Stryker Corp.
view allAdverse events under product code HBE
product code HBE- Injury
- 306
- Malfunction
- 7,175
- Other
- 1
- Total
- 7,482
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 K143399
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 K143399.
Data sourced from openFDA. This site is unofficial and independent of the FDA.