FDA.reportPublic FDA data

Tigon Medical

Primary DI
00810155331337
Brand
Tigon Medical
Company
Tigon Medical LLC
Model
TM-OSPP404-38S
Device description
4.5 mm x 38 mm Solid Screw - Partially Threaded
Published
2026-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240175000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240175000Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical2024-10-29HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810155331337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810155331337008101553313378101553313370810155331337

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080929031
Device count
1
Lot or batch
true
Sterilization required before use
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
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
00810155330378Tigon MedicalTM-GPSP001-2 2025-03-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613154320820MATTAStryker GmbHHWC2023-10-20
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