DEPUY SYNTHES MAXFRAME AUTOSTRUT System— 510(k) K231922
Substantially EquivalentDePuy Synthes
FDA 510(k) clearance K231922 for DEPUY SYNTHES MAXFRAME AUTOSTRUT System, Substantially Equivalent on 2023-07-26. Applicant: DePuy Synthes. Device class: 2.
Clearance details
- Applicant
- DePuy Synthes
- 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
- West Chester, PA, US
Recent devices under product code KTT
view allMore clearances from DePuy Synthes
view all- K233696 — DePuy Synthes Retrograde Femoral Nail Advanced System
- K233255 — CROSSNAV Navigation Enabled Instruments
- K233256 — Robotic Integration Instruments
- K233254 — TELIGEN System Navigation Ready Instruments
- K233665 — DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.