FDA.reportPublic FDA data

B2B Instruments

Primary DI
G463090512PK0
Brand
B2B Instruments
Company
BOXSPINE HOLDINGS, INC.
Model
09.0512PK
Catalog number
09.0512PK
Device description
4.35mm Stepped Anchor Pin
Published
2024-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HXBProbe
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G463090512PK0PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
126547906
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
G463066361BK0PLS06.6361B-K06.6361B-K2025-06-12
G463066362BK0PLS06.6362B-K06.6362B-K2025-06-12
G463066363BK0PLS06.6363B-K06.6363B-K2025-06-12
G463066364BK0PLS06.6364B-K06.6364B-K2025-06-12
G463066365BK0PLS06.6365B-K06.6365B-K2025-06-12
G463066380BK0PLS06.6380B-K06.6380B-K2025-06-12
G463066381BK0PLS06.6381B-K06.6381B-K2025-06-12
G463066382BK0PLS06.6382B-K06.6382B-K2025-06-12
G463066383BK0PLS06.6383B-K06.6383B-K2025-06-12
G463066384BK0PLS06.6384B-K06.6384B-K2025-06-12
G463066393BK0PLS06.6393B-K06.6393B-K2025-06-12
G463066394BK0PLS06.6394B-K06.6394B-K2025-06-12
G463066395BK0PLS06.6395B-K06.6395B-K2025-06-12
G463066396BK0PLS06.6396B-K06.6396B-K2025-06-12
G463066416BK0PLS06.6416B-K06.6416B-K2025-06-12
G463066417BK0PLS06.6417B-K06.6417B-K2025-06-12
G463066418BK0PLS06.6418B-K06.6418B-K2025-06-12
G463066419BK0PLS06.6419B-K06.6419B-K2025-06-12
G463066420BK0PLS06.6420B-K06.6420B-K2025-06-12
G463066421BK0PLS06.6421B-K06.6421B-K2025-06-12

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