FDA.report

Medtronic Reusable Instruments

Primary DI
00763000960599
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
EX5597511
Device description
REDUCER EX5597511 CLOSED
Published
2024-10-06
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

Related Records

Contact Domains

Product Codes

CodeName
HWNINSTRUMENT, COMPRESSION

Product Code Classifications

CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000960599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000960599007630009605997630009605990763000960599

GMDN Terms

TermDefinition
Orthopaedic rod reducerA heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 DIBrandModelCatalogPublished
00199150015429CD HORIZON® Spinal System593290202026-03-21
00199150015436CD HORIZON® Spinal System593290212026-03-21
00199150024469INFINITY™ Occipitocervical Upper Thoracic SystemNAV36500052026-03-22
00199150024483INFINITY™ Occipitocervical Upper Thoracic SystemNAV36062002026-03-22
00199150038138INFINITY™ Occipitocervical Upper Thoracic SystemNAV36500302026-03-21
00199150039524n/a36500042026-03-22
00199150044016Medtronic Reusable Instruments and Accessories65500252026-03-22
00199150051212Medtronic Reusable Instruments and AccessoriesRBT0901012026-03-22
00199150062263Medtronic Reusable InstrumentsEX10122552026-03-20
00199150062270Medtronic Reusable InstrumentsEX10122752026-03-20
00199150062287Medtronic Reusable InstrumentsEX10122902026-03-20
00199150066872Medtronic Reusable InstrumentsEX11250062026-03-20
00199150067343Medtronic Reusable InstrumentsEX12250162026-03-22
00199150067459Medtronic Reusable InstrumentsEX12250172026-03-20
00199150069675Medtronic Reusable InstrumentsX01260012026-03-20
00763000710194Medtronic Reusable Instruments and Accessories65520282026-03-22
00763000869069CD HORIZON® Spinal System593290142026-03-21
00763000869076CD HORIZON® Spinal System593290152026-03-21
00763000869090CD HORIZON® Spinal System593290172026-03-21
00763000869106CD HORIZON® Spinal System593290182026-03-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B922F005003608ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHWN2026-03-11
G079C5080000140MIS Golden Isles Pedicle Screw System Intelivation, LLCHWN2026-01-30
00199150061983Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWN2026-01-15
00888480530817Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHWN2026-01-13
03662663217040Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHWN2026-01-13
00840180543733General InstrumentsALPHATEC SPINE, INC.HWN2025-12-31
00840180544037General InstrumentsALPHATEC SPINE, INC.HWN2025-12-31
03662663244718Vital MIS Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-18
03662663198196Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-17
00840124525061Metalogix RevolutionFUSION ORTHOPEDICS, LLCHWN2025-12-16
03662663162326Zyston Interbody Spacer SystemHighridge Medical, LLCHWN2025-12-16
03662663195850Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195867Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195928Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195935Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195942Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195959Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195966Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195973Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195980Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663196000Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663196017Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663198189Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
00888480484912Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
00888480484929Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
00888480484936Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
03662663113199Virage OCT Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
03662663125895Vital MIS Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
03662663136884Polaris 4.75 Deformity SystemHighridge Medical, LLCHWN2025-12-03
03662663136891Polaris 4.75 Deformity SystemHighridge Medical, LLCHWN2025-12-03