3S HEMI TOE— 510(k) K072922
Substantially EquivalentTrilliant Surgical, Ltd.
FDA 510(k) clearance K072922 for 3S HEMI TOE, Substantially Equivalent on 2007-11-28. Applicant: Trilliant Surgical, Ltd.. Device class: 2.
Clearance details
- Applicant
- Trilliant Surgical, Ltd.
- Product code
- Code KWD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3730
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Round Rock, TX, US
Recent devices under product code KWD
view allMore clearances from Trilliant Surgical, Ltd.
view allAdverse events under product code KWD
product code KWD- Injury
- 164
- Total
- 164
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 K072922
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072922.
Data sourced from openFDA. This site is unofficial and independent of the FDA.