Integra External Fixation System— 510(k) K160830
Substantially EquivalentAscension Orthopedics
FDA 510(k) clearance K160830 for Integra External Fixation System, Substantially Equivalent on 2016-07-06. Applicant: Ascension Orthopedics. Device class: 2.
Clearance details
- Applicant
- Ascension Orthopedics
- 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
- Special
- Location
- Austin, TX, US
Recent devices under product code KTT
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view all- K182878 — Integra Salto Total Ankle System
- K162153 — Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System
- K152047 — INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
- K152527 — Integra DigiFuse Cannulated Intramedullary Fusion System
- K151459 — Integra Total Ankle Replacement System
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 →
Recalls naming K160830
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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160830.
Data sourced from openFDA. This site is unofficial and independent of the FDA.