OPTI-FIX TOTAL HIP SYSTEM— 510(k) K860635
Substantially Equivalent for Some IndicationsRichards Medical Co., Inc.
FDA 510(k) clearance K860635 for OPTI-FIX TOTAL HIP SYSTEM, Substantially Equivalent for Some Indications on 1986-03-14. Applicant: Richards Medical Co., Inc..
Clearance details
- Applicant
- Richards Medical Co., Inc.
- Product code
- Code LPH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Adverse events under product code LPH
product code LPH- Death
- 73
- Injury
- 31,640
- Malfunction
- 3,358
- Other
- 2
- Total
- 35,073
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.