FDA.reportPublic FDA data

N/A

Primary DI
00850030914095
Brand
N/A
Company
Microport Navibot International LLC
Model
B.B6.051-NB
Catalog number
BB6051NB
Device description
Base Probe Bracket
Published
2023-01-18
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
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213873000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213873000SkyWalker Total Knee SystemMicroport Navibot International, LLC2022-07-07OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850030914095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030914095008500309140958500309140950850030914095

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioning sensorA device designed to detect and respond to movement and transmits a signal proportional to the degree of motion. A parent device will receive these signals and show the position of the sensor and the object to which it is attached and make the necessary display/control adjustments for the object being monitored. It may be permanently attached to an electrical cable that relays energy to the sensor and signals back to the parent device. It may be affixed to the leg of a patient during computer assisted surgery (CAS) for implantation of a hip prosthesis to assist in the correct positioning of the implant or as a component of an electromagnetic device tracking system. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118104014
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850030914347SkyWalkerNB-10199NB-101992025-04-24
00850030914354SkyWalkerNB-10202NB-102022025-04-24
00850030914002N/A10016NB10016NB2023-01-19
00850030914019N/A10012NB10012NB2023-01-18
00850030914026N/A10008NBSUB10008NBSUB2023-01-18
00850030914262N/A10036-NBNB-101612023-01-18
00850030914279N/A10038-NBNB-101622023-01-18
00850030914286N/A10040-NBNB-101632023-01-18
00850030914309SkyWalkerNB-10137NB-101372023-06-29
00850030914316SkyWalkerNB-10139NB-101392023-06-29
20850030914266SkyWalkerNB-10148NB-101482023-06-29
20850030914273SkyWalkerNB-10149NB-101492023-06-29
20850030914280SkyWalkerNB-10150NB-101502023-06-29
00850030914149N/AE.Z.4641-NBNB-M00200582022-12-08
10850030914009N/A10016NB10016NB2023-01-19
10850030914016N/A10012NB10012NB2023-01-18
00850030914033N/AB.B6.055-NBB.B6.055NB2023-01-18
00850030914057N/AE.Z.4304-NBEZ4304NB2023-01-18
00850030914071N/AE.Z.4178-NBEZ4178NB2023-01-18
00850030914088N/AE.Z.4179-NBEZ4179NB2023-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376632919InvictusALPHATEC SPINE, INC.OLO2026-10-20
04056481147969Spine and Trauma NavigationBrainlab SEOLO2026-10-19
00889024673403NavitrackER®Orthosoft IncOLO2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699816ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699823ROSA® ShoulderOrthosoft IncOLO2026-06-26
00887868581083ROSA® RoboticsOrthosoft IncOLO2026-02-20
00889024703186ROSA® ShoulderOrthosoft IncOLO2026-01-27
00889024674790ROSA PIN STABILIZER 60MMOrthosoft IncOLO2025-12-12
00889024674776ROSA POLYAXIAL REFERENCE SIZE 3Orthosoft IncOLO2025-12-11
00889024674783ROSA POLYAXIAL REFERENCE SIZE 6Orthosoft IncOLO2025-12-11
00889024674806ROSA STABILIZER TISSUE DEFLECTOR 60MMOrthosoft IncOLO2025-12-11
00889024687455ROSA® KneeOrthosoft IncOLO2025-11-21
07613252286578FLUOROMAPStryker Leibinger GmbH & Co. KGOLO2025-01-28
00887868557873ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557880ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557897ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557903ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557910ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558078ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558092ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558160ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558177ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558306ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575105ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575112ROSA® ShoulderOrthosoft IncOLO2024-03-06