FDA.reportPublic FDA data

Navio

Primary DI
00885556631935
Brand
Navio
Company
Smith & Nephew, Inc.
Model
PFSR02050KT
Catalog number
PFSR02050KT
Device description
NAVIO INSTRUMENT KIT
Published
2016-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556631935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556631935008855566319358855566319350885556631935

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556838211Total Foot System 2280500728050072023-04-18
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055525225Onyx 4.5 mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525232Onyx 5.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525249Onyx 6.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525256Onyx 7.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525263Onyx 4.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525270Onyx 5.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525287Onyx 6.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525294Onyx 7.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525720Onyx Navigated Locking DriverSi-Bone Inc.OLO2026-09-30
00810055525966Onyx Navigated Locking Driver, CannulatedSi-Bone Inc.OLO2026-09-30
00810055526284Onyx iGPS Awl Tip Tap 4.5mmSi-Bone Inc.OLO2026-09-30
00810055526291Onyx iGPS Awl Tip Tap 5.5mmSi-Bone Inc.OLO2026-09-30
00810055526307Onyx iGPS Awl Tip Tap 6.5mmSi-Bone Inc.OLO2026-09-30
00810055526314Onyx iGPS Awl Tip Tap 7.5mmSi-Bone Inc.OLO2026-09-30
00810055526321Onyx iGPS DriverSi-Bone Inc.OLO2026-09-30
00810076335322MomentumUlrich Medical Usa, Inc.OLO2026-09-25
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOLO2026-09-25
00810131884062TiLink-L Rescue DilatorSurgentec, LLCOLO2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOLO2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOLO2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25
07613327460667Navigation EnabledStryker CorporationOLO2019-10-16
07613327460674Navigation EnabledStryker CorporationOLO2019-10-16
07613327460681Navigation EnabledStryker CorporationOLO2019-10-16
07613327460698Navigation EnabledStryker CorporationOLO2019-10-16
07613327460704Navigation EnabledStryker CorporationOLO2019-10-16
07613327460711Navigation EnabledStryker CorporationOLO2019-10-16
07613327460728Navigation EnabledStryker CorporationOLO2019-10-16
07613327460735Navigation EnabledStryker CorporationOLO2019-10-16