EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture Bolt— 510(k) K163497
Substantially EquivalentEncore Medical L.P.
FDA 510(k) clearance K163497 for EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture Bolt, Substantially Equivalent on 2017-03-02. Applicant: Encore Medical L.P.. Device class: 2.
Clearance details
- Applicant
- Encore Medical L.P.
- Product code
- Code KWZ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3310
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code KWZ
view allMore clearances from Encore Medical L.P.
view allAdverse events under product code KWZ
product code KWZ- Injury
- 993
- Total
- 993
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 K163497
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 K163497.
Data sourced from openFDA. This site is unofficial and independent of the FDA.