FDA.reportPublic FDA data

N/A

Primary DI
00850030914033
Brand
N/A
Company
Microport Navibot International LLC
Model
B.B6.055-NB
Catalog number
B.B6.055NB
Device description
Cutting Block w/Tool Probe
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
00850030914033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030914033008500309140338500309140330850030914033

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
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
00850030914347SkyWalkerNB-10199NB-101992025-04-24
00850030914354SkyWalkerNB-10202NB-102022025-04-24
00850030914149N/AE.Z.4641-NBNB-M00200582022-12-08
10850030914009N/A10016NB10016NB2023-01-19
10850030914016N/A10012NB10012NB2023-01-18
00850030914057N/AE.Z.4304-NBEZ4304NB2023-01-18
00850030914071N/AE.Z.4178-NBEZ4178NB2023-01-18
00850030914088N/AE.Z.4179-NBEZ4179NB2023-01-18
00850030914095N/AB.B6.051-NBBB6051NB2023-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606195546Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195553Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195560Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195577Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195584Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195591Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195607Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195614Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195621Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195638Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195645Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195652Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00885556925171REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925188REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925195REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925201REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925218REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925225REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925232REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925249REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
04054896090955VERTICALESilony Medical GmbHOLO2026-07-30
04054896090962VERTICALESilony Medical GmbHOLO2026-07-30
04054896090979VERTICALESilony Medical GmbHOLO2026-07-30
04054896090986VERTICALESilony Medical GmbHOLO2026-07-30
04054896090993VERTICALESilony Medical GmbHOLO2026-07-30
04054896091006VERTICALESilony Medical GmbHOLO2026-07-30
04054896091013VERTICALESilony Medical GmbHOLO2026-07-30
04054896091020VERTICALESilony Medical GmbHOLO2026-07-30
04054896091037VERTICALESilony Medical GmbHOLO2026-07-30
04054896091044VERTICALESilony Medical GmbHOLO2026-07-30