HGP II TOTAL HIP FEMERAL STEM— 510(k) K901364
Substantially Equivalent for Some IndicationsZimmer, Inc.
FDA 510(k) clearance K901364 for HGP II TOTAL HIP FEMERAL STEM, Substantially Equivalent for Some Indications on 1990-05-18. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code JDI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
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More clearances from Zimmer, Inc.
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- K260182 — Avenir® Müller Stem; Avenir Complete Hip System
- 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 JDI
product code JDI- Death
- 65
- Injury
- 12,943
- Malfunction
- 1,681
- Total
- 14,689
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.