ActivaScrew Cannulated COM— 510(k) K261057
Substantially EquivalentBioretec, Ltd.
FDA 510(k) clearance K261057 for ActivaScrew Cannulated COM, Substantially Equivalent on 2026-09-04. Applicant: Bioretec, Ltd.. Device class: 2.
Clearance details
- Applicant
- Bioretec, Ltd.
- 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
- Tampere, FI
Recent devices under product code HWC
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view all- DEN220030 — RemeOs Screw LAG Solid
- K133950 — ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)
- K130716 — BIORETEC ACTIVASCREW INTERFERENCE
- K080879 — ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM
- K081392 — BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.