FDA.reportPublic FDA data

Ball Joint Drill with Stop D3.5xL10

Primary DI
B806RO2102V1100
Brand
Ball Joint Drill with Stop D3.5xL10
Company
Spineup, Inc.
Model
RO2102V110
Catalog number
RO2102V110
Device description
Ball Joint Drill with Stop D3.5xL10
Published
2024-09-17
Public version status
New
Distribution status
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
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B806RO2102V1100PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
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
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
B806ISRO1214A06CB10ROMERO CERVICAL CAGE, W14xD12xH06ISRO1214A06CB1ISRO1214A06CB12023-08-28
B806ISRO1214A07CB10ROMERO CERVICAL CAGE, W14xD12xH07ISRO1214A07CB1ISRO1214A07CB12023-08-28
B806ISRO1214A08CB10ROMERO CERVICAL CAGE, W14xD12xH08ISRO1214A08CB1ISRO1214A08CB12023-08-28
B806ISRO1214A09CB10ROMERO CERVICAL CAGE, W14xD12xH09ISRO1214A09CB1ISRO1214A09CB12023-08-28
B806ISRO1214A10CB10ROMERO CERVICAL CAGE, W14xD12xH10ISRO1214A10CB1ISRO1214A10CB12023-08-28
B806ISRO1214A11CB10ROMERO CERVICAL CAGE, W14xD12xH11ISRO1214A11CB1ISRO1214A11CB12023-08-28
B806ISRO1214A12CB10ROMERO CERVICAL CAGE, W14xD12xH12ISRO1214A12CB1ISRO1214A12CB12023-08-28
B806ISRO1214A13CB10ROMERO CERVICAL CAGE, W14xD12xH13ISRO1214A13CB1ISRO1214A13CB12023-08-28
B806ISRO1214L04CB10ROMERO CERVICAL CAGE, W14xD12xH04ISRO1214L04CB1ISRO1214L04CB12023-08-24
B806ISRO1214L05CB10ROMERO CERVICAL CAGE, W14xD12xH05ISRO1214L05CB1ISRO1214L05CB12023-08-24
B806ISRO1214L06CB10ROMERO CERVICAL CAGE, W14xD12xH06ISRO1214L06CB1ISRO1214L06CB12023-08-24
B806ISRO1214L07CB10ROMERO CERVICAL CAGE, W14xD12xH07ISRO1214L07CB1ISRO1214L07CB12023-08-24
B806ISRO1214L08CB10ROMERO CERVICAL CAGE, W14xD12xH08ISRO1214L08CB1ISRO1214L08CB12023-08-24
B806ISRO1214L09CB10ROMERO CERVICAL CAGE, W14xD12xH09ISRO1214L09CB1ISRO1214L09CB12023-08-24
B806ISRO1214L10CB10ROMERO CERVICAL CAGE, W14xD12xH10ISRO1214L10CB1ISRO1214L10CB12023-08-24

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