FDA.reportPublic FDA data

510(k) K230764

Device
OsteoCentric Integrated Hip Fastener System
Applicant
OsteoCentric Technologies
510(k) number
K230764
Product code
JDO
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-18
Date received
2023-03-20
Regulation
888.3030
Classification name
Device, Fixation, Proximal Femoral, Implant
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Todd Evans
Address
75 W. 300 N. Suite 150 Logan UT US 84321 84321

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JDO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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.2022-09-29
K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma2021-04-30
K193029CONQUEST FNSmith & Nephew, Inc.2020-02-28
K173826THP Hip Fracture Plating SystemBiomet, Inc.2018-02-07
K172785CONQUEST FNSmith & Nephew2017-12-22
K152686CONQUEST FNSmith & Nephew2016-03-17
K140018TSP HIP FRACTURE PLATING SYSTEMBiomet, Inc.2014-04-04
K080685HIPLOC COMPRESSION HIP SCREWBiomet Manufacturing, Inc.2008-08-15
K080434INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREWSmith & Nephew, Inc.2008-04-10
K983814GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEMEfratgo, Ltd. HI Tech Bio-Surgical1999-01-14
K981757SYNTHES (USA) DHS HELIX SYSTEMSynthes (Usa)1998-07-17
K964259SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATIONSynthes (Usa)1997-01-09
K962644VIGOR COMPRESSION HIP SCREW SYSTEMDeutschland Surgical, Inc.1996-09-06
K953607TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS)Synthes (Usa)1996-03-08
K951904SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]Synthes (Usa)1995-07-17