OsteoCentric Integrated Hip Fastener System— 510(k) K210247
Substantially EquivalentOsteocentric Technologies D.B.A. Osteocentric Trauma
FDA 510(k) clearance K210247 for OsteoCentric Integrated Hip Fastener System, Substantially Equivalent on 2021-04-30. Applicant: Osteocentric Technologies D.B.A. Osteocentric Trauma. Device class: 2.
Clearance details
- Applicant
- Osteocentric Technologies D.B.A. Osteocentric Trauma
- 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
- Logan, UT, US
Recent devices under product code JDO
view all- K230764 — OsteoCentric Integrated Hip Fastener System
- 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
- K193029 — CONQUEST FN
- K173826 — THP Hip Fracture Plating System
- K172785 — CONQUEST FN
Data sourced from openFDA. This site is unofficial and independent of the FDA.