MS-30 FEMORAL STEM STANDARD AND LATERAL— 510(k) K040803
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K040803 for MS-30 FEMORAL STEM STANDARD AND LATERAL, Substantially Equivalent on 2004-04-29. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code LZO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Austin, TX, US
Recent devices under product code LZO
view allMore clearances from Zimmer, Inc.
view all- K261683 — Augment Off-Axis Instrument System
- K251840 — Zimmer® Persona® Personalized Knee System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
- K253566 — Affixus Retrograde Femoral Nailing System
- K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
Adverse events under product code LZO
product code LZO- Death
- 17
- Injury
- 12,942
- Malfunction
- 1,756
- Total
- 14,715
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 K040803
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 K040803.
Data sourced from openFDA. This site is unofficial and independent of the FDA.