FDA.reportPublic FDA data

Tigon Medical

Primary DI
00867430000440
Brand
Tigon Medical
Company
Tigon Medical LLC
Model
TIG60-TIGLASSO
Catalog number
TIG60-TIGLASSO
Device description
6.0 Lateral Anchor Knotless - Manticore with Suture Lasso
Published
2023-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MDIProsthesis, Rib Replacement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDIProsthesis, Rib ReplacementOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182507000Tigon Medical Tissue AnchorsTigon Medical2019-01-21MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867430000440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867430000440008674300004408674300004400867430000440

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080929031
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810155331191Tigon MedicalTM-ASAP002-03TT2025-12-11
00810155331207Tigon MedicalTM-ASAP003-04TTT2025-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840194498968Response Spine SystemORTHOPEDIATRICS CORP.MDI2026-01-29
00840194420006Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194420013Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194420037Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194420044Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422024Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422031Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422048Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422055Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422079Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422086Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422109Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422116Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422123Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422130Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422147Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422161Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422178Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422185Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422192Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422208Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422215Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422222Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422239Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194428163Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194428330Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194428347Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194428354Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
10705034734231NASynthes GmbHMDI2015-09-14
10705034734248NASynthes GmbHMDI2015-09-14