FDA.reportPublic FDA data

Tritis

Primary DI
10884521514133
Brand
Tritis
Company
Covidien LP
Model
8305SS
Device description
Nitinol Guide Wire
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052810000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052810000SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEMScandius Biomedical, Inc.2005-12-20MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521514133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452151413310884521514133

GMDN Terms#

Term, Definition table
TermDefinition
Meniscus screwA small, threaded, bioabsorbable rod intended to be used for the internal fixation of vertical lesions located in the vascularized area of the meniscus (a crescent-shaped disk of fibrocartilage that borders and partly covers the articulating surfaces of the tibia and femur at the knee). It is typically cannulated for guided percutaneous insertion. The device is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521171534Nellcor10005941-SG2022-10-01
10884521163454Nellcor100059412016-09-24
10884521196728NellcorPM100N2016-09-24
10884521527607NellcorDLPM100N2017-08-03
10884521527591NellcorDSPM100N2017-05-29
40884522004061ShileyDDCP2015-09-01
10884521815353MicrostreamPMC40M-PH2023-06-12
10884521543799SigniaSIGPSHELL2017-08-08
10884521856271Touch SurgeryMDS300012026-10-16
10884521701243INVOSPMAC71DOC2024-04-14
10884521810105INVOSPM71002021-06-14
10884521780170INVOSPMAC71DOC2019-07-31
10884521780071INVOSPM71002019-06-12
10884521839830TrexonCY904P2026-10-10
10884521839861TrexonCY954P2026-10-10
10884521840089TrexonCY811P2026-10-10
10884521840126TrexonCY843P2026-10-10
10884521840140TrexonCY883P2026-10-10
10884521840171TrexonCY953P2026-10-10
10884521840195TrexonGY123P2026-10-10

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Primary DI, Brand, Company table
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00888867627857Arthrex®ARTHREX, INC.MBI2026-10-07
00888867627864Arthrex®ARTHREX, INC.MBI2026-10-07
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20845854655501Argo KnotlessConmed CorporationMBI2026-09-25
20845854655518Argo KnotlessConmed CorporationMBI2026-09-25
00889024711280Jgrknt Reusable Fishmouth Perc GuideBiomet Orthopedics, LLCMBI2026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideBiomet Orthopedics, LLCMBI2026-08-25
00810198920178TeKBraceTheraMicro, LLCMBI2026-08-14
00811714036472ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
00811714036489ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
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00810146164692RedifixTRAX SURGICAL INC.MBI2026-07-20
00860016070004ICONN Revolution 6.5MM Knotless Suture AnchorICONN ORTHOPEDICS LLCMBI2026-07-16