DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT— 510(k) K132912
Substantially EquivalentIn2bones Sas
FDA 510(k) clearance K132912 for DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT, Substantially Equivalent on 2014-07-30. Applicant: In2bones Sas. Device class: 2.
Clearance details
- Applicant
- In2bones Sas
- 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
- Potomac, MD, US
Recent devices under product code HWC
view allMore clearances from In2bones Sas
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 K132912
K-number listed on FDA's recall record- Z-1318-2015 — DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
- Z-1319-2015 — DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132912.
Data sourced from openFDA. This site is unofficial and independent of the FDA.