HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC— 510(k) K912263
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K912263 for HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC, Substantially Equivalent on 1991-08-29. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code MEH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
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Adverse events under product code MEH
product code MEH- Injury
- 2,021
- Total
- 2,021
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.