VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES— 510(k) K073499
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K073499 for VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES, Substantially Equivalent on 2008-08-07. Applicant: Zimmer, Inc.. Device class: 3.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code JDL
- Device class
- Class 3
- Regulation
- 21 CFR 888.3320
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code JDL
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- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
Adverse events under product code JDL
product code JDL- Injury
- 285
- Total
- 285
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.