Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007014520

FEI Number

3007014520

Entity Name

Remington Medical, Inc.

City/State/Country

Alpharetta, GA, US

Establishment Address

6245 Shiloh Road, Suite C, Alpharetta, GA 30005, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

REMINGTON MEDICAL, INC. (Owner Number: 9006473)

Owner / Operator Contact Address

6830 MEADOWRIDGE CT., --, Alpharetta, GA 30005, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K971968

PMA Number

N/A

All Registered Proprietary Names

LNGC-14 LNGO-2022 LNGC-2022 Pneumatic Button Cable Myelotec Video Guided Steerable Catheter VascuChek Transceiver VascuChek Clinical Probe VascuChek Charger VascuChek Kit VascuChek System TendoNova Ocelot TDS 1000 Adapter Cap Bionix Internal Feeding Tube Declogger McKesson Internal Feeding Tube Declogger VascuChek ADAP-1 Family FL-601-97 Family BS-101-97 Family ADAP-2R Family PA-801 Family 301-CG Family ADAP-2000 Family ADAP-2RL Family S-201-97 Family ADAP-2 Family S-101-97 Family FL-II Family

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2026-01-28
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-28
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2007-11-09
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-02-19
ORZ	Eyelid Thermal Pulsation System	Ophthalmic	Class 2	886.5200	2014-08-28
ORZ	Eyelid Thermal Pulsation System	Ophthalmic	Class 2	886.5200	2021-05-26
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2014-11-17
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2014-11-17
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2026-01-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-28
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2025-11-20
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2021-05-05
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2022-07-15
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-05-28
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2023-04-04
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2017-08-01
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-28
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2021-10-12
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2022-09-29
ORZ	Eyelid Thermal Pulsation System	Ophthalmic	Class 2	886.5200	2017-01-20
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2026-01-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-28
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	2026-01-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-03-05
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2025-06-27
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2022-12-13
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2025-11-21
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2023-05-02
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2026-01-28
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2026-01-28
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2026-01-28
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2026-01-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-28
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2023-05-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-01-28
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2007-11-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

REMINGTON MEDICAL, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009265194	Remington Medical, S.A.	Santo Domingo Este, DO
1056553	REMINGTON MEDICAL, INC.	ALPHARETTA, GA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880088	Cadwell Laboratories, Inc.	CADWELL EXCEL	1988-05-04
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03
K092467	Brainlab AG	VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED	2010-05-06
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Z-0007-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007014520. Last updated year: 2026. Please use registration number 3007014520 when referencing this establishment in official correspondence.