BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH— 510(k) K905262
Substantially Equivalent for Some IndicationsEndotec, Inc.
FDA 510(k) clearance K905262 for BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH, Substantially Equivalent for Some Indications on 1993-05-19. Applicant: Endotec, Inc.. Device class: 2.
Clearance details
- Applicant
- Endotec, Inc.
- Product code
- Code JDI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- South Orange, NJ, US
Recent devices under product code JDI
view all- K253515 — Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments
- K253434 — OSSTM Orthopedic Salvage System
- K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
- K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
- K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
More 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 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.