BUECHEL-PAPPAS HUMERAL STEM COMPONENT— 510(k) K904880
Substantially EquivalentEndotec, Inc.
FDA 510(k) clearance K904880 for BUECHEL-PAPPAS HUMERAL STEM COMPONENT, Substantially Equivalent on 1991-01-28. Applicant: Endotec, Inc.. Device class: 2.
Clearance details
- Applicant
- Endotec, Inc.
- Product code
- Code KWS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Orange, NJ, US
Recent devices under product code KWS
view allMore clearances from Endotec, Inc.
view all- K081400 — FANNING-PAPPAS MODULAR KNEE BEARING
- K012702 — BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1
- K992394 — BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
- K982418 — BUECHEL-PAPPAS MODULAR SALVAGE STEM
- K963100 — TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP
Adverse events under product code KWS
product code KWS- Death
- 6
- Injury
- 9,652
- Malfunction
- 1,385
- Other
- 1
- Total
- 11,044
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.