FDA.reportPublic FDA data

Ball Joint Tap with Stop D3.5xL17

Primary DI
B806RO2109V1170
Brand
Ball Joint Tap with Stop D3.5xL17
Company
Spineup, Inc.
Model
RO2109V117
Catalog number
RO2109V117
Device description
Ball Joint Tap with Stop D3.5xL17
Published
2024-09-17
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
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B806RO2109V1170PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
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
B806ISRO1214A05CB10ROMERO CERVICAL CAGE, W14xD12xH05ISRO1214A05CB1ISRO1214A05CB12023-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400552MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400576MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400644MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402075MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402082MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402204MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400293MillenniumAvalign Technologies, Inc.HTW2026-07-17
18257200076536CETRAOrthofix US LLCHTW2026-07-17
18257200076574CETRAOrthofix US LLCHTW2026-07-17
18257200131211Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200131228Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200131273Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200163823PILLAR SA TiOrthofix US LLCHTW2026-07-17
18257200163854PILLAR SA TiOrthofix US LLCHTW2026-07-17
07630008439866APTUSMedartis AGHTW2026-07-16
07630037811374APTUSMedartis AGHTW2026-07-16
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09353903030324OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
00190776395438MillenniumAvalign Technologies, Inc.HTW2026-07-13
00190446932406Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948216Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948483Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
09353903030218Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-06-24
00889795154507Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154514Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154521Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154606Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
08800089483433Drill bitJeil Medical CorporationHTW2026-06-10
08800089483457Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTW2026-06-10