SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM— 510(k) K083439
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K083439 for SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM, Substantially Equivalent on 2009-02-05. Applicant: Synthes (Usa). Device class: 2.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code MBF
- Device class
- Class 2
- Regulation
- 21 CFR 888.3670
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
Recent devices under product code MBF
view all- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
- K251098 — Identity Revision Humeral Stems
- K250848 — Identity Shoulder System
- K240876 — Identity Shoulder System
- K233712 — PRIMA Humeral System; PRIMA TT Glenoid
More clearances from Synthes (Usa)
view all- K141527 — DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
- K131984 — SYNTHES SYNSONIC ULNA NAIL
- K121601 — SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
- K120854 — SYNTHES VA LCP ANKLE TRAUMA SYSTEM
- K120717 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
Adverse events under product code MBF
product code MBF- Injury
- 597
- Total
- 597
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.