FDA.reportPublic FDA data

Anatomic Access LLIF

Primary DI
00196449034192
Brand
Anatomic Access LLIF
Company
Tyber Medical, LLC
Model
81180008
Device description
Anatomic Access LLIF, Rotating Shaver 8mm
Published
2025-10-22
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
HTZINSTRUMENT, CUTTING, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196449034192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449034192001964490341921964490341920196449034192

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)761-0933ra@tybermed.com

Regulatory Flags#

DUNS number
010968002
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
00810040684050Cannulated Compression Headless Screw03.333.31203.333.3122020-08-20
00196449021161VOLT™ Wrist Treatment System02.426.6452026-04-10
00196449021178VOLT™ Wrist Treatment System04.426.6452026-04-10
00196449021185VOLT™ Wrist Treatment System02.426.6462026-04-10
00196449021192VOLT™ Wrist Treatment System02.426.6472026-04-10
00196449021208VOLT™ Wrist Treatment System04.426.6462026-04-10
00196449021215VOLT™ Wrist Treatment System04.426.6472026-04-10
00196449021222VOLT™ Wrist Treatment System02.426.2502026-04-10
00196449021239VOLT™ Wrist Treatment System02.426.2552026-04-10
00196449021246VOLT™ Wrist Treatment System02.426.2602026-04-10
00196449021253VOLT™ Wrist Treatment System04.426.2502026-04-10
00196449021260VOLT™ Wrist Treatment System04.426.2552026-04-10
00196449021277VOLT™ Wrist Treatment System04.426.2602026-04-10
00196449021888VOLT™ Wrist Treatment System02.426.7332026-04-10
00196449021895VOLT™ Wrist Treatment System02.426.7322026-04-10
00196449021901VOLT™ Wrist Treatment System04.426.7332026-04-10
00196449021918VOLT™ Wrist Treatment System04.426.7322026-04-10
00196449021925VOLT™ Wrist Treatment System02.426.9112026-04-10
00196449021932VOLT™ Wrist Treatment System02.426.9102026-04-10
00196449021949VOLT™ Wrist Treatment System02.426.9212026-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295552390ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-05-18
07649988948701SPIRECUTSPIRECUT SAHTZ2026-05-04
07649988948718SPIRECUTSPIRECUT SAHTZ2026-05-04
00196449033454Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449033461Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449033591Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449033676Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034185Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034208Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034673Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034680Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034697Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
B471293000100GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000150GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000200GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000250GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
10886982339492NASynthes GmbHHTZ2024-10-09
10887587077611NASynthes GmbHHTZ2024-08-21
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