INTEGRA EXTERNAL FIXATION SYSTEM— 510(k) K140463
Substantially EquivalentAscension Orthopedic
FDA 510(k) clearance K140463 for INTEGRA EXTERNAL FIXATION SYSTEM, Substantially Equivalent on 2014-10-10. Applicant: Ascension Orthopedic. Device class: 2.
Clearance details
- Applicant
- Ascension Orthopedic
- 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
- Providence, UT, US
Recent devices under product code KTT
view allMore clearances from Ascension Orthopedic
view allAdverse 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 →
Recalls naming K140463
K-number listed on FDA's recall record- Z-2386-2016 — Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219
- Z-2387-2016 — Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
- Z-2296-2016 — Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140463.
Data sourced from openFDA. This site is unofficial and independent of the FDA.