FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00613994375117
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0906194
Device description
HANDLE X0906194 NIM PROBE BALL ATT
Published
2022-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994375117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994375117006139943751176139943751170613994375117

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating systemAn multicomponent assembly of electrically-powered devices designed to locate a nerve by applying an electrical stimulus with a probe and observing muscle responses. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators it does not display electromyography (EMG) readings. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169190382CLYDESDALE PTC™ Spinal System49268552016-04-17
00643169190399CLYDESDALE PTC™ Spinal System49268502016-04-17
00643169190405CLYDESDALE PTC™ Spinal System49268452016-04-18
00643169190412CLYDESDALE PTC™ Spinal System49268402016-04-17
00643169190429CLYDESDALE PTC™ Spinal System49266602016-04-17
00643169190436CLYDESDALE PTC™ Spinal System49266552016-04-17
00643169190443CLYDESDALE PTC™ Spinal System49266502016-04-17
00643169190450CLYDESDALE PTC™ Spinal System49266452016-04-18
00643169190467CLYDESDALE PTC™ Spinal System49266402016-04-18
00643169190481CLYDESDALE PTC™ Spinal System49264552016-04-18
00643169190504CLYDESDALE PTC™ Spinal System49868602016-04-17
00643169190559CLYDESDALE PTC™ Spinal System49866602016-04-17
00643169190566CLYDESDALE PTC™ Spinal System49866552016-04-17
00643169190573CLYDESDALE PTC™ Spinal System49866502016-04-17
00643169190580CLYDESDALE PTC™ Spinal System49866452016-04-17
00643169190597CLYDESDALE PTC™ Spinal System49866402016-04-17
00643169190603CLYDESDALE PTC™ Spinal System49864602016-04-17
00643169190610CLYDESDALE PTC™ Spinal System49864552016-04-18
00643169190634CLYDESDALE PTC™ Spinal System49864452016-04-17
00643169190658CLYDESDALE PTC™ Spinal System49862602016-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986489425LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
08809986489432LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
M9432002230000Liberty SISpinal Simplicity, LLCLXH2026-08-19
00198506093937ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00198506094194ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00810130207534MSIModern Surgical Instruments LLCLXH2026-08-18
00810198920345General InstrumentsTheraMicro, LLCLXH2026-08-18
00810198920352TeKForceTheraMicro, LLCLXH2026-08-18
00810198920376TeKForceTheraMicro, LLCLXH2026-08-18
00850078396396ActivaScrew™ Cannulated COM Single-Use Accessory Kit 3.5/4.0/4.5 mm(1054)Eca Medical InstrumentsLXH2026-08-18
08053782781652Bioplan Instruments KitBRM EXTREMITIES SRLLXH2026-08-18
08057717553635BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553642BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553659BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553666BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553673BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553680BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553697BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553703BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553710BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553727BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553734BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553741BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553758BRM BIOPLAN INSTRUMENTSBRM EXTREMITIES SRLLXH2026-08-18
08800104097980Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.LXH2026-08-18
08800322750834PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322758106PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322758113PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759523QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759530QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18