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FDA 510(k)

OsteoCentric Integrated Hip Fastener System

K-Number: K230764 · 2023-04-18

ApplicantOsteoCentric Technologies
Decision Date2023-04-18
Product CodeJDO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoCentric Integrated Hip Fastener System is a medical device manufactured by OsteoCentric Technologies. It received FDA 510(k) clearance on 2023-04-18 under approval number K230764. 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 2023-04-18. It is manufactured by OsteoCentric Technologies. The 510(k) number is K230764.

When was OsteoCentric Integrated Hip Fastener System approved by the FDA?

OsteoCentric Integrated Hip Fastener System received FDA 510(k) clearance on 2023-04-18, under approval number K230764.

What company makes OsteoCentric Integrated Hip Fastener System?

OsteoCentric Integrated Hip Fastener System is manufactured by OsteoCentric Technologies.

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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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by OsteoCentric Technologies

K211290Cannulated Fasteners and Nuts K210754Cannulated Fasteners and Nuts K222512Integrity-SI Fusion System K221332OsteoCentric Spine MIS Pedicle Fastener System K230242OsteoCentric Dental Implant System K230226Integrity-SI® Fusion System

View all 11 devices →

Related Devices (Code: JDO)

K152686CONQUEST FNSmith & Nephew K172785CONQUEST FNSmith & Nephew K173826THP Hip Fracture Plating SystemBiomet, Inc. K193029CONQUEST FNSmith & Nephew, Inc. K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma 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.

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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