FDA.reportPublic FDA data

Tigon Medical

Primary DI
00810155330002
Brand
Tigon Medical
Company
Tigon Medical LLC
Model
TM-NDCT557-M
Device description
5.5 mm x 72 mm Metal Cannula
Published
2025-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810155330002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810155330002008101553300028101553300020810155330002

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic access cannula, reusableA single-lumen, surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080929031
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810155331412Tigon MedicalTM-SASP001-04S2026-07-09
00850029805106Tigon MedicalTIG255-39SSTIG255-39SS2026-06-26
00810155330989Tigon MedicalTM-KASP001-01S2026-02-04
00810155331214Tigon MedicalTM-KASP001-04S2026-02-04
00810155331283Tigon MedicalTM-OSPP404-48S2026-02-04
00810155331290Tigon MedicalTM-OSPP404-46S2026-02-04
00810155331306Tigon MedicalTM-OSPP404-44S2026-02-04
00810155331313Tigon MedicalTM-OSPP404-42S2026-02-04
00810155331320Tigon MedicalTM-OSPP404-40S2026-02-04
00810155331337Tigon MedicalTM-OSPP404-38S2026-02-04
00810155331344Tigon MedicalTM-OSPP404-36S2026-02-04
00810155331351Tigon MedicalTM-OSPP404-34S2026-02-04
00810155331368Tigon MedicalTM-OSPP404-32S2026-02-04
00810155331375Tigon MedicalTM-OSPP404-30S2026-02-04
00810155331382Tigon MedicalTM-OSPP404-28S2026-02-04
00810155330095Tigon MedicalTM-NDCT0132024-11-06
00810155331276Tigon MedicalTIGT7512-U2026-01-23
00810155331160Tigon MedicalTM-ASAP003-04TLS2025-12-11
00810155331177Tigon MedicalTM-ASAP003-04TLT2025-12-11
00810155331184Tigon MedicalTM-ASAP001-04T2025-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
00840606174923PrimusSPINAL ELEMENTS, INC.LXH2026-09-22
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
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B7682460370Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-09-24
B7682440010Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-06-20
B7682459240Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-05-30
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B7682459260Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B768345211500Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
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B7685211080Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B7685215150Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B7685271430Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27