FDA.reportPublic FDA data

Cervical Screw Driver Shaft Straight Quick Connect

Primary DI
B806GN0011T08S0
Brand
Cervical Screw Driver Shaft Straight Quick Connect
Company
Spineup, Inc.
Model
GN0011T08S
Catalog number
GN0011T08S
Device description
Cervical Screw Driver Shaft Straight Quick Connect
Published
2024-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B806GN0011T08S0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
786-910-0234contact@upgroup.tech

Regulatory Flags#

DUNS number
116999578
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B806RO2100V1080Ball Joint Tap with Stop D3.5xL08RO2100V108RO2100V1082024-09-17
B806RO2101V1090Ball Joint Tap with Stop D3.5xL09RO2101V109RO2101V1092024-09-17
B806RO2102V1100Ball Joint Tap with Stop D3.5xL10RO2102V110RO2102V1102024-09-17
B806RO2103V1110Ball Joint Tap with Stop D3.5xL11RO2103V111RO2103V1112024-09-17
B806RO2104V1120Ball Joint Tap with Stop D3.5xL12RO2104V112RO2104V1122024-09-17
B806RO2105V1130Ball Joint Tap with Stop D3.5xL13RO2105V113RO2105V1132024-09-17
B806RO2106V1140Ball Joint Tap with Stop D3.5xL14RO2106V114RO2106V1142024-09-17
B806RO2107V1150Ball Joint Tap with Stop D3.5xL15RO2107V115RO2107V1152024-09-17
B806RO2108V1160Ball Joint Tap with Stop D3.5xL16RO2108V116RO2108V1162024-09-17
B806RO2109V1170Ball Joint Tap with Stop D3.5xL17RO2109V117RO2109V1172024-09-17
B806RO2110V1180Ball Joint Tap with Stop D3.5xL18RO2110V118RO2110V1182024-09-17
B806RO2111V1190Ball Joint Tap with Stop D3.5xL19RO2111V119RO2111V1192024-09-17
B806RO2112V1200Ball Joint Tap with Stop D3.5xL20RO2112V120RO2112V1202024-09-17
B806RO0002LFIX0Romero Lateral Finishing Impactor XLRO0002LFIXRO0002LFIX2024-10-14
B806RO0027FIZZ0Romero Finishing ImpactorRO0027FIZZRO0027FIZZ2024-10-14
B806RO0028LFIZ0Romero Lateral Finishing ImpactorRO0028LFIZRO0028LFIZ2024-10-14
B806ISRO1214L08CA10ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH08ISRO1214L08CA1ISRO1214L08CA12023-10-03
B806ISRO1420L13CA10ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH13ISRO1420L13CA1ISRO1420L13CA12023-10-04
B806ISRO1620A12CA10ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH12ISRO1620A12CA1ISRO1620A12CA12023-10-03
B806ISRO1214A04CB10ROMERO CERVICAL CAGE, W14xD12xH04ISRO1214A04CB1ISRO1214A04CB12023-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD1455810020Surgical DirectSurgical Direct, Inc.HXX2026-09-29
B382SD1455810030Surgical DirectSurgical Direct, Inc.HXX2026-09-29
10886982345462VOLTSynthes GmbHHXX2026-09-25
00840606197342OmegaSPINAL ELEMENTS, INC.HXX2026-09-22
07640139343185BAGUERA C INSTRUMENTATIONSpineArt SAHXX2026-08-27
00843210143644Monaco Pedicle Screw SystemAltus Spine, LLCHXX2026-08-24
00199150083091Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-22
B095329646Hintermann SeriesDt Medtech, LLCHXX2026-08-21
00199150083459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08
00199150083466Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08
00199150076468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-03
00199150076475Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-03
00840606191616Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191623Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191746Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191753Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191784Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191944Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191951Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191982Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
03701089540643AMPLITUDEAMPLITUDE SASHXX2026-07-29
03701089541022AMPLITUDEAMPLITUDE SASHXX2026-07-29
03700569670269Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569674649Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569679859Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569680282Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569680299Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
00824846003199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
00824846003205Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
10887587078557NASynthes GmbHHXX2026-07-24