PROVEN MODULAR POSTERIOR STABILIZED FEMORAL— 510(k) K021908
Substantially EquivalentStelkast Company
FDA 510(k) clearance K021908 for PROVEN MODULAR POSTERIOR STABILIZED FEMORAL, Substantially Equivalent on 2002-07-09. Applicant: Stelkast Company. Device class: 2.
Clearance details
- Applicant
- Stelkast Company
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mcmurray, PA, US
Recent devices under product code JWH
view allMore 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
- K081458 — PROVEN STEM EXTENDER
- K063211 — PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
Adverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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 →
Recalls naming K021908
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021908.
Data sourced from openFDA. This site is unofficial and independent of the FDA.