ALLOFIX ANCHOR, 5.0 MM ANCHOR— 510(k) K061498
Substantially EquivalentMusculoskeletal Transplant Foundation
FDA 510(k) clearance K061498 for ALLOFIX ANCHOR, 5.0 MM ANCHOR, Substantially Equivalent on 2006-07-06. Applicant: Musculoskeletal Transplant Foundation. Device class: 2.
Clearance details
- Applicant
- Musculoskeletal Transplant Foundation
- Product code
- Code JDW
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edison, NJ, US
Recent devices under product code JDW
view allMore clearances from Musculoskeletal Transplant Foundation
view allAdverse events under product code JDW
product code JDW- Injury
- 717
- Total
- 717
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 K061498
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 K061498.
Data sourced from openFDA. This site is unofficial and independent of the FDA.