MTF Pre-Sutured Tendon— 510(k) K181633
Substantially EquivalentMusculoskeletal Transplant Foundation
FDA 510(k) clearance K181633 for MTF Pre-Sutured Tendon, Substantially Equivalent on 2019-03-15. Applicant: Musculoskeletal Transplant Foundation. Device class: 2.
Clearance details
- Applicant
- Musculoskeletal Transplant Foundation
- Product code
- Code GAT
- Device class
- Class 2
- Regulation
- 21 CFR 878.5000
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edison, NJ, US
Recent devices under product code GAT
view allMore clearances from Musculoskeletal Transplant Foundation
view allAdverse events under product code GAT
product code GAT- Death
- 19
- Injury
- 4,163
- Malfunction
- 8,646
- Other
- 2
- Total
- 12,830
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 K181633
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 K181633.
Data sourced from openFDA. This site is unofficial and independent of the FDA.