FDA.reportPublic FDA data

N/A

Primary DI
00850030914217
Brand
N/A
Company
Microport Navibot International LLC
Model
E.Z.5420-NB
Catalog number
EZ5420NB
Device description
Leg Positioner Clamp
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
00850030914217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030914217008500309142178500309142170850030914217

GMDN Terms#

Term, Definition table
TermDefinition
Leg procedure positionerA non-powered, patient-contact, preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during a medical/surgical procedure (e.g., orthopaedic surgery, examination, office procedure), or during patient transfer to an operating table; it is not intended for application of traction forces. It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating/examination table are typically included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118104014
Device count
1
Lot or batch
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
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

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Primary DI, Brand, Company table
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00840493426433RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426440RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426457RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426464RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426471RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426495RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426501RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426587RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426594RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
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00193982622114DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
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00763000995195Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-08-14
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00763000995232Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-08-14