FDA.report

Medtronic Reusable Instruments

Primary DI
00673978047768
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
825-220
Device description
INSTRUMENT 825-220 CABLE CRIMPER
Published
2022-11-26
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
HXQCRIMPER, PIN

Product Code Classifications

CodeDeviceSpecialtyClass
HXQCrimper, PinOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00673978047768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00673978047768006739780477686739780477680673978047768

GMDN Terms

TermDefinition
Internal spinal fixation system cable crimp, non-sterileA non-sterile implantable device intended to be used as part of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is used to lock implanted spinal fixation cable(s) after the surgeon has appropriately tensioned them. It is made of high-grade stainless steel alloy or medical grade titanium (Ti), and is locked around the cable with a dedicated cable crimper.

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
00841823100375Leadwire Connection CrimperAd-Tech Medical Instrument CorporationHXQ2023-08-31
04026575295371Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575295388Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575431557LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575431564LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575431588LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575431595LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575438204LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575031047LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575341474LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-20
04026575216703SPARK - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-15
04026575216710SPARK - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-15
04026575216727SPARK - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-15
04026575216734SPARK - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-15
04026575216758TrabecuLink Femoral and Tibial Cone - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-15
04026575216765TrabecuLink Femoral and Tibial Cone - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-15
04026575216772TrabecuLink Femoral and Tibial Cone - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-15
04026575157679LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-14
04026575431571LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-14
04026575436811LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-14
04026575436828LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-14
04026575436835LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-14
00613994808264Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXQ2022-11-27
08800017278148LOSPA IS Spinal SystemCorentec Co., LtdHXQ2022-10-21
08800017278155LOSPA IS Spinal SystemCorentec Co., LtdHXQ2022-10-21
08800017278162LOSPA IS Spinal SystemCorentec Co., LtdHXQ2022-10-21
08800017278179LOSPA IS Spinal SystemCorentec Co., LtdHXQ2022-10-21
00673978145372Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXQ2022-10-07
04047844018828CERVICAL PLATING SYSTEMSIGNUS Medizintechnik GmbHHXQ2022-06-01
05060079820355Chiroklip wire protector 2 pack blisterOSTEOTEC LIMITEDHXQ2022-02-04