ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM— 510(k) K090596
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K090596 for ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM, Substantially Equivalent on 2009-06-30. 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
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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 K090596
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 K090596.
Data sourced from openFDA. This site is unofficial and independent of the FDA.