FDA.reportPublic FDA data

THE ORTHOPAEDIC IMPLANT COMPANY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30085999793008599979THE ORTHOPAEDIC IMPLANT COMPANY1Y2026-01-01770 Smithridge Dr Ste 400 Reno NV US 89502

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1211981261292109K983495SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420HWC1998-12-16
1211981071014190K242995OIC Small / Mini Fragment Plate SystemHRS2024-10-23
1211982057786212K233531OIC FLEX-FIX™ SystemHTN2024-02-02
1211981312591010K223761OIC Intramedullary Screw SystemHWC2023-02-13
1211981811950831K223118OIC Variable Angle Small Fragment Locking Plate SystemHRS2023-01-21
1211981508735159K212601DRPx Locking Distal Radius Plate SystemHRS2022-04-05
1211981326138636K202971DRPx Locking Distal Radius Plate SystemHRS2021-05-06
1211981996608485K182736OIC Suture Anchor SystemMBI2018-12-28
1211981106004808K181184OIC Intramedullary Nail SystemHSB2018-07-27
1211981711619905K171211OIC External Fixation SystemKTT2017-09-27
1211981514335596K150655OIC Intramedullary Nail SystemHSB2015-07-09
1211981109140745K140357OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEMHRS2014-06-09
1211981714416291K123832OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGMEHRS2013-03-20
1211981729682950K113123OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEMKTT2012-01-12
1211981010679491K110046ATHENA PEDICLE SCREW SYSTEMNKB2011-12-07
1211981840550816K092540C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACERODP2010-01-27
1211981804663428K091309REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXXHSB2009-11-05
1211981106832477K082260INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGESMAX2008-10-17
1211981478582488K072562MICROWARE BONE PLATES AND BONE SCREWSHRS2008-12-04
1211981456652500
1211981541578460

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS92024-10-23
HSB52018-07-27
KTT42017-09-27
HWC22023-02-13
MBI22018-12-28
ODP22010-01-27
HTN12024-02-02
NKB12011-12-07
MAX12008-10-17

PMN#