FDA.reportPublic FDA data

Cervical Drill Revision with Stop L16

Primary DI
B806GN0098D2160
Brand
Cervical Drill Revision with Stop L16
Company
Spineup, Inc.
Model
GN0098D216
Catalog number
GN0098D216
Device description
Cervical Drill Revision with Stop L16
Published
2024-09-30
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
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B806GN0098D2160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. 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

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Primary DI, Brand, Company table
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00888867574557Arthrex®ARTHREX, INC.HTW2026-09-18
10810128463079OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463086OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463185OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463192OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
00884450681381Preston™Merit Medical Systems, Inc.HTW2026-08-21
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00840606191791Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191807Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
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00840606191821Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191852Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195768Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195775Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00190376544397InvictusALPHATEC SPINE, INC.HTW2026-07-30
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00190376544410InvictusALPHATEC SPINE, INC.HTW2026-07-30
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00190376544465InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544472InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544489InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544861InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544878InvictusALPHATEC SPINE, INC.HTW2026-07-30
03701089515153AMPLITUDEAMPLITUDE SASHTW2026-07-29