FDA.reportPublic FDA data

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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXQCRIMPER, PIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXQCrimper, PinOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673978047768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673978047768006739780477686739780477680673978047768

GMDN Terms#

Term, Definition table
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 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
00763000703929MSB CAPSTONE CONTROL™ Spinal System39914222026-08-27
00763000703936MSB CAPSTONE CONTROL™ Spinal System39914272026-08-27
00763000703950MSB CAPSTONE CONTROL™ Spinal System39915222026-08-27
00763000703967MSB CAPSTONE CONTROL™ Spinal System39915272026-08-27
00763000703981MSB CAPSTONE CONTROL™ Spinal System39916222026-08-27
00763000703998MSB CAPSTONE CONTROL™ Spinal System39916272026-08-27
00763000704001MSB CAPSTONE CONTROL™ Spinal System39916322026-08-27
00763000704018MSB CAPSTONE CONTROL™ Spinal System39917222026-08-27
00763000704025MSB CAPSTONE CONTROL™ Spinal System39917272026-08-27
00763000704032MSB CAPSTONE CONTROL™ Spinal System39917322026-08-27
00763000704049MSB CAPSTONE CONTROL™ Spinal System39913322026-08-27
00763000704063MSB CAPSTONE CONTROL™ Spinal System39908272026-08-27
00763000704070MSB CAPSTONE CONTROL™ Spinal System39909222026-08-27
00763000704100MSB CAPSTONE CONTROL™ Spinal System39910272026-08-27
00763000704117MSB CAPSTONE CONTROL™ Spinal System39910322026-08-27
00763000704124MSB CAPSTONE CONTROL™ Spinal System39911222026-08-27
00763000704131MSB CAPSTONE CONTROL™ Spinal System39911272026-08-27
00763000704148MSB CAPSTONE CONTROL™ Spinal System39911322026-08-27
00763000704155MSB CAPSTONE CONTROL™ Spinal System39912222026-08-27
00763000704162MSB CAPSTONE CONTROL™ Spinal System39912272026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124521872PolyLock MidfootFUSION ORTHOPEDICS, LLCHXQ2025-10-02
00841823100375Leadwire Connection CrimperAd-Tech Medical Instrument CorporationHXQ2023-08-31
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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
04026575317967LINK Instruments - Alignment and positioning instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-16
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
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08800017278179LOSPA IS Spinal SystemCorentec Co., LtdHXQ2022-10-21
00673978145372Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXQ2022-10-07