PROFEMUR Z CLASSIC STEMS— 510(k) K123434
Substantially EquivalentWrightmedicaltechnologyinc
FDA 510(k) clearance K123434 for PROFEMUR Z CLASSIC STEMS, Substantially Equivalent on 2013-02-05. Applicant: Wrightmedicaltechnologyinc. Device class: 2.
Clearance details
- Applicant
- Wrightmedicaltechnologyinc
- 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
- Arlington, TN, US
Recent devices under product code LZO
view allMore clearances from Wrightmedicaltechnologyinc
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 K123434
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 K123434.
Data sourced from openFDA. This site is unofficial and independent of the FDA.