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FDA 510(k)

OsteoCentric Integrated Hip Fastener System

K-Number: K210247 · 2021-04-30

ApplicantOsteocentric Technologies D.B.A. Osteocentric Trauma
Decision Date2021-04-30
Product CodeJDO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: JDO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric TechnologiesK213126Smith & 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 & NephewK152686CONQUEST FNSmith & Nephew

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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