FDA.reportPublic FDA data

Tigon Medical

Primary DI
00850029805809
Brand
Tigon Medical
Company
Tigon Medical LLC
Model
TIGO-56
Catalog number
TIGO-13
Device description
4.8 mm Tomahawk Tap
Published
2025-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00850029805809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850029805809008500298058098500298058090850029805809

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
410-544-2833quality@tigonmedical.com

Regulatory Flags#

DUNS number
080929031
Device count
1
Premarket exempt
true
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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00196449035328Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035335Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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00196449035472Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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