ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)— 510(k) K133950
Substantially EquivalentBioretec, Ltd.
FDA 510(k) clearance K133950 for ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.), Substantially Equivalent on 2014-01-22. Applicant: Bioretec, Ltd.. Device class: 2.
Clearance details
- Applicant
- Bioretec, Ltd.
- Product code
- Code HTY
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tampere, FI
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Adverse events under product code HTY
product code HTY- Injury
- 544
- Total
- 544
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.