ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM— 510(k) K951000
Substantially EquivalentJoint Medical Products Corp.
FDA 510(k) clearance K951000 for ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM, Substantially Equivalent on 1995-04-14. Applicant: Joint Medical Products Corp..
Clearance details
- Applicant
- Joint Medical Products Corp.
- Product code
- Code LPH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, 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.