EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED— 510(k) K033634
Substantially EquivalentCenterpulse Orthopedics, Inc.
FDA 510(k) clearance K033634 for EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED, Substantially Equivalent on 2004-09-15. Applicant: Centerpulse Orthopedics, Inc.. Device class: 3.
Clearance details
- Applicant
- Centerpulse Orthopedics, Inc.
- Product code
- Code KWA
- Device class
- Class 3
- Regulation
- 21 CFR 888.3330
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code KWA
view allMore clearances from Centerpulse Orthopedics, Inc.
view allAdverse events under product code KWA
product code KWA- Death
- 38
- Injury
- 10,439
- Malfunction
- 1,862
- Total
- 12,339
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 K033634
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 K033634.
Data sourced from openFDA. This site is unofficial and independent of the FDA.