Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008599979

FEI Number

3008599979

Entity Name

THE ORTHOPAEDIC IMPLANT COMPANY

City/State/Country

Reno, NV, US

Establishment Address

770 Smithridge Dr Ste 400, Reno, NV 89502, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

The Orthopaedic Implant Company (Owner Number: 10033702)

Owner / Operator Contact Address

770 Smithridge Dr, STE 400, Reno, NV 89502, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OIC INTRAMEDULLARY NAIL SYSTEM OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM OIC CLAVICLE PLATING SYSTEM OIC DISTAL RADIUS PLATING SYSTEM OIC PROXIMAL HUMERUS PLATING SYSTEM OIC DRILL BIT OIC INTRAMEDULLARY NAIL SYSTEM OIC INTRAMEDULLARY SCREW SYSTEM OIC SUTURE ANCHOR SYSTEM OIC CANNULATED SCREW SYSTEM OIC SLIDING HIP SCREW SYSTEM OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM OIC DORSAL SPANNING PLATE OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM OIC CERVICAL CAGE DRPx Distal Radius Plate System OIC General Surgical Instruments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-07-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-06-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-06-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-05-08
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2011-01-05
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2015-07-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-02-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-01-02
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2012-04-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-04-11
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2010-10-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-10-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2010-10-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-04-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-03-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-03-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-10-16
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2012-10-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-05-24
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-05-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-05-24
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2010-12-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

The Orthopaedic Implant Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Similar Registrations

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3015207155	Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008599979. Last updated year: 2026. Please use registration number 3008599979 when referencing this establishment in official correspondence.