Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009826895

FEI Number

3009826895

Entity Name

MEDICAL DEVICE AND IMPLANTS LLC

City/State/Country

Lancaster, PA, US

Establishment Address

Medical Device and Implants LLC, 1824 and 1813 Colonial Village Lane, Lancaster, PA 17601, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Medical Device and Implants LLC (Owner Number: 10042103)

Owner / Operator Contact Address

Medical Device and Implants LLC DBA Spitrex MDI, 1824 and 1813 Colonial Village Lane, Lancaster, PA 17601, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Trauma Integrated Hip System Geminus Plating System Appliance, Fixation, Nail/Blade/Plate Combination, Multiple CoLink Mini CoLink Mini Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Vilex, Inc. Smooth or Threaded Metallic Bone Fixation Fastener Small Bone Nailing System Reduct Headless Compression Screw System Smooth or Threaded Metallic Bone Fixation Fastener Trauma Cannulated Fastener Skeletal Dynamics Humeras Plating System Skeletal Dynamics Forearm Plating System STYLOID SCREW (MOD T5 DRIVE) 2 mm X 28mm STYLOID SCREW (MOD T5 DRIVE) 2 mm X 30mm STYLOID SCREW (MOD T5 DRIVE) 2 m Intervertebral Body Fusion Device Intervertebral Body Fusion Device Geminus Plating System Stabllyx Implant System Smooth or Threaded Metallic Bone Fixation Fastener Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Kinos Axiom Total Ankle System Reduct Headless Compression Screw System Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Vilex, Inc. Precise Distal Radial Volar Plate CORT SCREW LOCKING SELF TAPPING T6 2.7mm X 10mm CORT SCREW LOCKING SELF TAPPING T6 2.7mm X 14mm CORT SCREW LOCKING SELF Trauma Fasteners Reference Toe System (RTS) Tyber Medical Trauma Screw, Headed RibFix Advantage System Manticore Anchor System CoLink Afx Plating System Skeletal Dynamics Humeras Plating System PROTEAN Fragment Plating System Tyber Medical Trauma Screw, Headless Align Radial Head System Hand Trauma Screw System Distal Elbow Plating System Intervertebral Body Fusion Device Intervertebral Body Fusion Device Spinal Intervertebral Body Fusion Orthosis Spinal Intervertebral Body Fusion Orthosis Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Smooth or Threaded Metallic Bone Fixation Fastener TyFix Screw Smooth or Threaded Metallic Bone Fixation Fastener Trauma Locking Fastener Vilex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JDO	Device, Fixation, Proximal Femoral, Implant	Orthopedic	Class 2	888.3030	2022-06-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-15
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-12-06
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-07-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-05-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-05-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-26
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2019-03-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-26
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2022-07-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-06-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-03-01
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-07-15
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-07-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-15
KYI	Prosthesis, Wrist, Carpal Trapezium	Orthopedic	Class 2	888.3770	2022-07-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-26
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2022-07-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-12-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-12-14
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2019-03-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-12-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-06-23
KWH	Prosthesis, Toe, Constrained, Polymer	Orthopedic	Class 2	888.3720	2022-07-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-06-23
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-01-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-19
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-06-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-06-23
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2022-07-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-15
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-07-15
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-07-15
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-07-15
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-06-23
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-12-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-07-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-06-23
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2019-03-04

Official Correspondent

Donald Mowry

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medical Device and Implants LLC

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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009826895. Last updated year: 2026. Please use registration number 3009826895 when referencing this establishment in official correspondence.