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Data / Medical devices / United States / The Orthopaedic Implant Company

The Orthopaedic Implant Company: FDA-registered device maker in Reno, NV, United States, 17 510(k) clearances

The Orthopaedic Implant Company is registered with the FDA (registration 3008599979) in Reno, NV, United States. It lists 10 device types. The FDA files 17 510(k) clearances under its listings, the newest dated October 23, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch The Orthopaedic Implant Company
FDA registration number
3008599979
Address
770 Smithridge Dr Ste 400, Reno, NV, United States, 89502
Owner or operator
The Orthopaedic Implant Company (10033702)
Roles
Specification developer
First device listed
October 5, 2010
Registered through
2026
Brand names listed
DRPx Distal Radius Plate System, FlexFix Syndesmosis Repair Kit, OIC ANKx System, OIC CANNULATED SCREW SYSTEM, OIC CERVICAL CAGE, OIC CLAVICLE PLATING SYSTEM, OIC Clavicle Plates, OIC DISTAL RADIUS PLATING SYSTEM and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Specification developeraccessdata.fda.gov
Bit, DrillHTW1Specification developeraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Specification developeraccessdata.fda.gov
Plate, Fixation, BoneHRS2Specification developeraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Specification developeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Specification developeraccessdata.fda.gov
Washer, Bolt NutHTN2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 23, 2024K242995OIC Small / Mini Fragment Plate SystemHRSSubstantially EquivalentThe Orthopaedic Implant Companyaccessdata.fda.gov
February 2, 2024K233531OIC FLEX-FIX™ SystemHTNSubstantially EquivalentOrthopaedic Implant Companyaccessdata.fda.gov
February 13, 2023K223761OIC Intramedullary Screw SystemHWCSubstantially EquivalentOrthopaedic Implant Companyaccessdata.fda.gov
January 21, 2023K223118OIC Variable Angle Small Fragment Locking Plate SystemHRSSubstantially EquivalentOrthopaedic Implant Companyaccessdata.fda.gov
April 5, 2022K212601DRPx Locking Distal Radius Plate SystemHRSSubstantially EquivalentOrthopaedic Implant Companyaccessdata.fda.gov
May 6, 2021K202971DRPx Locking Distal Radius Plate SystemHRSSubstantially EquivalentOrthopaedic Implant Companyaccessdata.fda.gov
December 28, 2018K182736OIC Suture Anchor SystemMBISubstantially EquivalentThe Orthopaedic Implant Companyaccessdata.fda.gov
July 27, 2018K181184OIC Intramedullary Nail SystemHSBSubstantially EquivalentThe Orthopaedic Implant Companyaccessdata.fda.gov
September 27, 2017K171211OIC External Fixation SystemKTTSubstantially EquivalentOrthopaedic Implant Companyaccessdata.fda.gov
July 9, 2015K150655OIC Intramedullary Nail SystemHSBSubstantially EquivalentOrthopaedic Implant Companyaccessdata.fda.gov
June 9, 2014K140357OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEMHRSSubstantially EquivalentOrthopaedic Implant Companyaccessdata.fda.gov
March 20, 2013K123832OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGMEHRSSubstantially EquivalentThe Orthopaedic Implant Company (Oic)accessdata.fda.gov
January 12, 2012K113123OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEMKTTSubstantially EquivalentThe Orthopaedic Implant Companyaccessdata.fda.gov
January 27, 2010K092540C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACERODPSubstantially EquivalentRsb Spine, LLCaccessdata.fda.gov
November 5, 2009K091309REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXXHSBSubstantially EquivalentDgimed Ortho, Inc.accessdata.fda.gov
December 4, 2008K072562MICROWARE BONE PLATES AND BONE SCREWSHRSSubstantially EquivalentMicroware Precision Co., Ltd.accessdata.fda.gov
December 16, 1998K983495SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420HWCSubstantially EquivalentSyntec Scientific Corp.accessdata.fda.gov

Compare with other makers

Updated October 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.