Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1060840

FEI Number

3000205819

Entity Name

ODYSSEY MEDICAL TECHNOLOGIES, LLC

City/State/Country

Bartlett, TN, US

Establishment Address

2975 Brother Blvd., Bartlett, TN 38133, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ODYSSEY MEDICAL TECHNOLOGIES LLC (Owner Number: 9024079)

Owner / Operator Contact Address

2975 Brother Blvd, --, Bartlett, TN 38133, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vilex External Fixation System Back-Pak Discectomy Set FUZE Intramedullary Internal Fixation Nail Vilex Cannulated Bone Screw Double Thread True Position Pivoting Spacer System Minuteman G5 Rebar Cervical Spacer System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2012-11-28
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2012-11-28
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-11-19
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2012-11-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-11-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-11-19
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2024-08-13
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2012-11-19

Official Correspondent

Richard Von Staden

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ODYSSEY MEDICAL TECHNOLOGIES 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
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20
K223112	Smith & Nephew, Inc.	MAVERICK Mini External Fixation System	2022-12-08
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3044090645	MEDUSA ORTHOPEDICS, LLC	Fleetwood, PA, US
3021680719	QUALITEX NE LLC	Columbia City, IN, US
3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3015869121	Jabil Switzerland Manufacturing GmbH (Raron)	Raron Valais, CH
1043653	ONYX MEDICAL LLC	MEMPHIS, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1060840. Last updated year: 2026. Please use registration number 1060840 when referencing this establishment in official correspondence.