FDA.reportPublic FDA data

N/A

Primary DI
10850030914283
Brand
N/A
Company
Microport Navibot International LLC
Model
10040-NB
Catalog number
NB-10163
Device description
Nail Pouched
Published
2023-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
10850030914283PackageGS12In Commercial Distribution
00850030914286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003091428310850030914283
00850030914286008500309142868500309142860850030914286

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118104014
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424989RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424996RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493425009RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13