ORTHOPEDIC ALLIANCE SPINE SYSTEM— 510(k) K033826
Substantially EquivalentOrthopedic Alliance, LLC
FDA 510(k) clearance K033826 for ORTHOPEDIC ALLIANCE SPINE SYSTEM, Substantially Equivalent on 2004-07-01. Applicant: Orthopedic Alliance, LLC. Device class: 2.
Clearance details
- Applicant
- Orthopedic Alliance, LLC
- Product code
- Code MNI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murrieta, CA, US
Recent devices under product code MNI
view allMore clearances from Orthopedic Alliance, LLC
view allAdverse events under product code MNI
product code MNI- Injury
- 641
- Total
- 641
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 K033826
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 K033826.
Data sourced from openFDA. This site is unofficial and independent of the FDA.