BIORETEC ACTIVASCREW INTERFERENCE— 510(k) K130716
Substantially EquivalentBioretec, Ltd.
FDA 510(k) clearance K130716 for BIORETEC ACTIVASCREW INTERFERENCE, Substantially Equivalent on 2013-08-28. Applicant: Bioretec, Ltd.. Device class: 2.
Clearance details
- Applicant
- Bioretec, Ltd.
- Product code
- Code MAI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tampere, FI
Recent devices under product code MAI
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- K133950 — ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)
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- K081392 — BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN
Adverse events under product code MAI
product code MAI- Injury
- 1,948
- Malfunction
- 8,580
- Total
- 10,528
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.