ONE-PIECE PEEK FUSION IMPLANT— 510(k) K140970
Substantially EquivalentMtp Solutions, LLC
FDA 510(k) clearance K140970 for ONE-PIECE PEEK FUSION IMPLANT, Substantially Equivalent on 2014-05-13. Applicant: Mtp Solutions, LLC. Device class: 2.
Clearance details
- Applicant
- Mtp Solutions, LLC
- 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
- Special
- Location
- Logan, UT, US
Recent devices under product code HWC
view allMore clearances from Mtp Solutions, LLC
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.