EMPOWR Partial Knee— 510(k) K191325
Substantially EquivalentEncore Medical L.P.
FDA 510(k) clearance K191325 for EMPOWR Partial Knee, Substantially Equivalent on 2019-07-16. Applicant: Encore Medical L.P.. Device class: 2.
Clearance details
- Applicant
- Encore Medical L.P.
- Product code
- Code HSX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3520
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code HSX
view allMore clearances from Encore Medical L.P.
view allAdverse events under product code HSX
product code HSX- Injury
- 1,003
- Other
- 1
- Total
- 1,004
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 K191325
K-number listed on FDA's recall record- Z-0479-2021 — EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
- Z-0480-2021 — EMPOWR Partial Knee Peg Drill; Model: 800-06-008.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191325.
Data sourced from openFDA. This site is unofficial and independent of the FDA.