ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS— 510(k) K083497
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K083497 for ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS, Substantially Equivalent on 2009-02-19. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code HSB
view all- K261481 — Pangea Femur Reconstruction System
- K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
- K261651 — Precice Max System and Precice Ankle Salvage System
- K253155 — Fule Metallic Lockable Intramedullary Nail Systems
- K253046 — HERA Interlocking Intramedullary Nailing System
More clearances from Zimmer, Inc.
view all- K260831 — Z1 Hip System
- K261683 — Augment Off-Axis Instrument System
- K251840 — Zimmer® Persona® Personalized Knee System
- K260182 — Avenir® Müller Stem; Avenir Complete Hip System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
Adverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
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 K083497
K-number listed on FDA's recall record- Z-2599-2017 — Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV
- Z-2060-2015 — ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083497.
Data sourced from openFDA. This site is unofficial and independent of the FDA.