FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00673978145372
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0797-035
Device description
PROV CRIMP W/ MOD THUMB LEVER
Published
2022-10-07
Public version status
Update
Distribution status
Not 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
HXQCRIMPER, PIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXQCrimper, PinOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673978145372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673978145372006739781453726739781453720673978145372

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation system cable crimperA scissors-like, heavy-duty, hand-held manual surgical instrument specifically designed to compress (pinch) fixation crimps that are applied to spinal fixation cable(s). The device is used in conjunction with a cable tensioner to lock into final position the cables used to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is typically designed to be operated by a surgeon with the cable(s) in situ. 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
00643169016798Medtronic Reusable InstrumentsX06110012022-11-27
00643169016804Medtronic Reusable InstrumentsX06110022022-11-27
00673978816241Medtronic Reusable InstrumentsX06990402022-11-27
00613994423559N/AX07072142022-11-14
00613994423566N/AX07072152022-11-14
00613994423573N/AX07072162022-11-14
00613994423603N/AX07072192022-11-14
00643169588219Medtronic Resuable InstrumentsX08108352022-11-14
00643169860940Medtronic Resuable InstrumentsX07160322022-11-14
00643169860957Medtronic Resuable InstrumentsX07160332022-11-14
00613994107169Medtronic Reusable InstrumentsX08050732022-10-07
00613994230676Medtronic Reusable InstrumentsX07061412022-10-07
00613994404510Medtronic Reusable InstrumentsX07061942022-10-07
00613994507129Medtronic Reusable InstrumentsX08081362022-10-07
00613994507150Medtronic Reusable InstrumentsX08081392022-10-07
00613994507174Medtronic Reusable InstrumentsX08081412022-10-07
00613994838797Medtronic Reusable InstrumentsX06102712022-10-07
00613994838803Medtronic Reusable InstrumentsX06102702022-10-07
00613994838841Medtronic Reusable InstrumentsX06102662022-10-07
00613994866011Medtronic Reusable InstrumentsX08108102022-10-07

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
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
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
00673978047768Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXQ2022-11-26
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