FDA.reportPublic FDA data

OsteoCentric Technologies,Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30116563263011656326OsteoCentric Technologies,Inc1N2026-01-0175W 300N Suite 150 Logan UT US 84321

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1839821955098532K251913OsteoCentric® UnifiMI® TCS Plating SystemHRS2025-08-16
1839821048186402K250520OsteoCentric Navigated Instruments SystemOLO2025-10-27
1839821029665830K250494The OsteoCentric Bone Plate and Screw SystemHRS2025-03-18
1839821475946693K242691OsteoCentric Technologies Cannulated Fasteners and NutsHWC2024-10-09
1839821162420577K230764OsteoCentric Integrated Hip Fastener SystemJDO2023-04-18
1839821938150666K230595OsteoCentric ACL Fixation SystemHWC2023-06-29
1839821239884538K230242OsteoCentric Dental Implant SystemDZE2023-10-05
1839821163093896K230226Integrity-SI® Fusion SystemOUR2023-09-21
1839821978240596K222512Integrity-SI Fusion SystemOUR2022-09-12
1839822051803138K221332OsteoCentric Spine MIS Pedicle Fastener SystemNKB2022-07-28
1839821142043804K211290Cannulated Fasteners and NutsHWC2021-08-03
1839821418822910K210754Cannulated Fasteners and NutsHWC2021-04-14
1839821114776024K210247OsteoCentric Integrated Hip Fastener SystemJDO2021-04-30
1839821997670647K200259Headless Compression Screw SystemHWC2020-05-04
1839821458499279K190430OsteoCentric Bone Plate and Screw SystemHWC2019-03-22
1839821060988835K182171SMV Scientific K-Wire and PinsJDW2018-10-25
1839821305398843K170021SMV Scientific Cannulated ScrewsHWC2017-05-22
1839821480599059K161755Integrity-SI TM Fusion SystemOUR2016-12-14
1839822031377578K1609464.0 and 6.5 Cancellous Bone Screw and WasherHWC2016-12-05
1839821302020124K160603SMV Scientific Schanz ScrewsHWC2016-03-28
1839822044811087K152000SMV Scientific Bone Plate and Screw SystemHRS2015-11-25
1839821112483699K150981SMV Scientific Bone ScrewsHWC2015-06-23
1839821543876706K150188SMV Scientific 4.5 mm Bone ScrewsHWC2015-04-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC112024-10-09
HRS32025-08-16
OUR32023-09-21
JDO22023-04-18
OLO12025-10-27
DZE12023-10-05
NKB12022-07-28
JDW12018-10-25