PARADIGM INTERSPINOUS FUSION PLATE— 510(k) K093438
Substantially EquivalentParadigm Spine, LLC
FDA 510(k) clearance K093438 for PARADIGM INTERSPINOUS FUSION PLATE, Substantially Equivalent on 2010-10-06. Applicant: Paradigm Spine, LLC. Device class: 2.
Clearance details
- Applicant
- Paradigm Spine, LLC
- Product code
- Code KWP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3050
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recent devices under product code KWP
view allMore clearances from Paradigm Spine, LLC
view allAdverse events under product code KWP
product code KWP- Death
- 7
- Injury
- 1,539
- Malfunction
- 1,519
- Total
- 3,065
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 K093438
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 K093438.
Data sourced from openFDA. This site is unofficial and independent of the FDA.