Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1833053

FEI Number

1833053

Entity Name

INNOMED, INC.

City/State/Country

SAVANNAH, GA, US

Establishment Address

103 Estus Dr, SAVANNAH, GA 31404, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

INNOMED, INC. (Owner Number: 1833053)

Owner / Operator Contact Address

103 ESTUS DR., --, Savannah, GA 31404, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Probe for LED Disposable Light Source LED Disposable Light Source (package of 10) Wixson Femoral Horizontal Attachment Positioning Rings Pkg of 12 Threaded Pin Driver #K0001205 Universal Table Adapter Universal Table Adapter & Traction Device Assembly Bone Holding Reduction Double Curved Clamp Browner Wire Tightener Case Tray Nicholson Shoulder Extractor Assistant Free 5" Wide Standard Blade

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTX	Rongeur	Orthopedic	Class 1	888.4540	2013-03-28
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2021-10-25
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2013-03-31
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2001-11-20
HXB	Probe	Orthopedic	Class 1	888.4540	2013-03-28
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2020-06-25
KIL	Positioner, Socket	Orthopedic	Class 1	888.4540	2016-11-18
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-03-31
HTO	Reamer	Orthopedic	Class 1	888.4540	2016-11-22
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2015-11-04
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2017-05-26
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2013-03-28
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2015-03-17
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2013-03-19
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-10-31
HWB	Extractor	Orthopedic	Class 1	888.4540	2001-11-20
HXG	Tamp	Orthopedic	Class 1	888.4540	2013-03-31
JEB	Table, Surgical With Orthopedic Accessories, Manual	General, Plastic Surgery	Class 1	878.4950	2017-02-23
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2018-11-02
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2013-03-27
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2013-03-28
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2016-11-18
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2013-03-28
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2013-03-28
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2013-03-28
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-03-19
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2013-03-28
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2013-03-28
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2001-11-20
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2020-11-18
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-03-06
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2013-03-31
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2001-11-20
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-11-16
HWJ	Awl	Orthopedic	Class 1	888.4540	2016-10-31
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2016-12-09
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-03-06
KQW	Goniometer, Nonpowered	Orthopedic	Class 1	888.1520	2016-12-09

Official Correspondent

JAMES ANDERSON

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INNOMED, INC.

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
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

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.

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3011577940	Titan Spine, a Division of Medtronic	Milwaukee, WI, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1833053. Last updated year: 2026. Please use registration number 1833053 when referencing this establishment in official correspondence.