SRRS PRESSED FIT FEMORAL REVISION COMPONENT— 510(k) K960908
Substantially EquivalentStelkast Company
FDA 510(k) clearance K960908 for SRRS PRESSED FIT FEMORAL REVISION COMPONENT, Substantially Equivalent on 1996-08-08. Applicant: Stelkast Company. Device class: 2.
Clearance details
- Applicant
- Stelkast Company
- Product code
- Code LWJ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3360
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pittsburgh, PA, US
Recent devices under product code LWJ
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- K081458 — PROVEN STEM EXTENDER
- K063211 — PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
Adverse events under product code LWJ
product code LWJ- Injury
- 544
- Total
- 544
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.