FDA.reportPublic FDA data

N/A

Primary DI
00199150002139
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
59325013
Device description
COUNTERTORQUE 59325013 HMC CONNECTOR
Published
2026-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00199150002139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199150002139001991500021391991500021390199150002139

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic counter-torque/rod-pushing instrumentA hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. This is a reusable device.

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169236967n/a74806532026-10-11
00643169236974n/a74806522026-10-11
00643169236981n/a74806512026-10-11
00763000857851T2 STRATOSPHERE™ Expandable Corpectomy System43612582026-10-11
00763000857950T2 STRATOSPHERE™ Expandable Corpectomy System43612252026-10-11
00763000874209MSB SHILLA Growth Guidance System76745002026-10-11
00763000885502MSB Reusable Instruments7080921D2026-10-11
00824846010722Medtronic Reusable InstrumentsX07260022026-10-09
00643169964938GRAFTON™ DBMT42275INT2024-12-05
00643169965102GRAFTON PLUS™ DBMT45005INT2024-11-15
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUS0005052021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUS0050012021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUS0050052021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUS0051102021-03-12
00763000140540PROGENIX™ PUTTY and PROGENIX™ PLUS0060012021-03-12
00763000140557PROGENIX™ PUTTY and PROGENIX™ PLUS0060022021-03-12
00763000140564PROGENIX™ PUTTY and PROGENIX™ PLUS0060052021-03-12
00763000140571PROGENIX™ PUTTY and PROGENIX™ PLUS0060102021-03-12
00643169965089GRAFTON® DBMT44150INT2019-02-07
00613994247612PROGENIX® PUTTY and PROGENIX® PLUS0051102019-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434762MillenniumAvalign Technologies, Inc.LXH2026-10-12
00850080243176OSTEOROD Delivery SystemBONE SOLUTIONS, INC.LXH2026-10-12
00889795150264APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-10-12
B0842003000000Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000010Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000020Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000030Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000100Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000110Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000120Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000130Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000200Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000210Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000220Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000230Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000300Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000310Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000320Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000330Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000400Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000410Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000420Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000430Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000500Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000510Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000520Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000530Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000600Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000610Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000620Keos Lumbar InstrumentKEOSLXH2023-02-10