MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM— 510(k) K033664
Substantially EquivalentCenterpulse Orthopedics, Inc.
FDA 510(k) clearance K033664 for MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM, Substantially Equivalent on 2003-12-17. Applicant: Centerpulse Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Centerpulse Orthopedics, 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 Centerpulse Orthopedics, Inc.
view allAdverse 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 K033664
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 K033664.
Data sourced from openFDA. This site is unofficial and independent of the FDA.