SUMMIT TOTAL HIP SYSTEM— 510(k) K942891
Substantially EquivalentKirschner Medical Corp.
FDA 510(k) clearance K942891 for SUMMIT TOTAL HIP SYSTEM, Substantially Equivalent on 1994-11-02. Applicant: Kirschner Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Kirschner Medical Corp.
- 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
- Fair Lawn, NJ, US
Recent devices under product code MEH
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view all- K940537 — KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM
- K936274 — KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM
- K941486 — INTEGRITY TOTAL HIP SYSTEM, NON-POROUS
- K933843 — LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED
- K935951 — KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM
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.