REPROCESSED EXTERNAL FIXATION DEVICE— 510(k) K061759
Substantially EquivalentAscent Healthcare Solutions
FDA 510(k) clearance K061759 for REPROCESSED EXTERNAL FIXATION DEVICE, Substantially Equivalent on 2006-09-05. Applicant: Ascent Healthcare Solutions. Device class: 2.
Clearance details
- Applicant
- Ascent Healthcare Solutions
- Product code
- Code KTT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Phoenix, AZ, US
Recent devices under product code KTT
view allMore clearances from Ascent Healthcare Solutions
view all- K111600 — REPROCESSED HAND ACTIVATE SEALER/DIVIDER
- K110189 — REPROCESSED ELECTROSURGICAL INSTRUMENT
- K100909 — REPROCESSED COMPRESSION SLEEVES
- K100254 — REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
- K100537 — REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
Adverse events under product code KTT
product code KTT- Death
- 11
- Injury
- 3,097
- Malfunction
- 1,261
- Total
- 4,369
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.