FDA.reportPublic FDA data

NA

Primary DI
10705034775852
Brand
NA
Company
Synthes GmbH
Model
389.479
Catalog number
389479
Device description
ALIGNMENT TOOL
Published
2016-12-31
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
07611819753129Direct MarkingGS10
10705034775852PrimaryGS10
H9813894790SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819753129076118197531297611819753129
1070503477585210705034775852

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
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
10887587060743ChronOS710.000.98S71000098S2015-09-14
10887587060774ChronOS710.003.98S71000398S2015-09-14
10887587060781ChronOS710.011.98S71001198S2015-09-14
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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