26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER— 510(k) K991622
Substantially EquivalentStelkast Company
FDA 510(k) clearance K991622 for 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER, Substantially Equivalent on 1999-07-14. Applicant: Stelkast Company. Device class: 2.
Clearance details
- Applicant
- Stelkast Company
- Product code
- Code JDI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pittsburgh, PA, US
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More clearances from Stelkast Company
view all- K122883 — EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM
- K122773 — CROSS-OVER ACETABULAR SHELL & LINER
- K094035 — EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM
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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.