ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT— 510(k) K032812
Substantially EquivalentOrthovita, Inc.
FDA 510(k) clearance K032812 for ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT, Substantially Equivalent on 2003-12-08. Applicant: Orthovita, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthovita, Inc.
- Product code
- Code MQP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malver, PA, US
Recent devices under product code MQP
view allMore clearances from Orthovita, Inc.
view allAdverse events under product code MQP
product code MQP- Injury
- 372
- Malfunction
- 519
- Total
- 891
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 K032812
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 K032812.
Data sourced from openFDA. This site is unofficial and independent of the FDA.