FDA 510(k)

OsteoCentric Integrated Hip Fastener System

K-Nummer: K210247 · 2021-04-30

AntragstellerOsteocentric Technologies D.B.A. Osteocentric Trauma

Entscheidungsdatum2021-04-30

ProduktcodeJDO

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

OsteoCentric Integrated Hip Fastener System is the device name listed in this FDA 510(k) record. The listed applicant is Osteocentric Technologies D.B.A. Osteocentric Trauma. It received FDA 510(k) clearance on 2021-04-30 under 510(k) number K210247. The device is classified under product code JDO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the OsteoCentric Integrated Hip Fastener System?

OsteoCentric Integrated Hip Fastener System is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Osteocentric Technologies D.B.A. Osteocentric Trauma. The 510(k) number is K210247.

When did OsteoCentric Integrated Hip Fastener System receive FDA 510(k) clearance?

OsteoCentric Integrated Hip Fastener System received FDA 510(k) clearance on 2021-04-30, under 510(k) number K210247.

Who is the listed applicant for OsteoCentric Integrated Hip Fastener System?

The FDA 510(k) record lists Osteocentric Technologies D.B.A. Osteocentric Trauma as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoCentric Integrated Hip Fastener System?

The FDA product code for OsteoCentric Integrated Hip Fastener System is JDO.

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Verwandte Geräte (Code: JDO)

K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screwsSmith & Nephew, Inc.K193029CONQUEST FNSmith & Nephew, Inc.K173826THP Hip Fracture Plating SystemBiomet, Inc.K172785CONQUEST FNSmith & Nephew K152686CONQUEST FNSmith & Nephew

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