SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]— 510(k) K951904
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K951904 for SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX], Substantially Equivalent on 1995-07-17. Applicant: Synthes (Usa). Device class: 2.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code JDO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paoli, PA, US
Recent devices under product code JDO
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- K213126 — Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws
- K210247 — OsteoCentric Integrated Hip Fastener System
- K193029 — CONQUEST FN
- K173826 — THP Hip Fracture Plating System
More clearances from Synthes (Usa)
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- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.