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
00196449002511LEOS Cannulated Screw System76312008763120082023-12-08
00196449002528LEOS Cannulated Screw System76312010763120102023-12-08
00196449002535LEOS Cannulated Screw System76312012763120122023-12-08
00196449002542LEOS Cannulated Screw System76312014763120142023-12-08
00196449002559LEOS Cannulated Screw System76312016763120162023-12-08
00196449002566LEOS Cannulated Screw System76312018763120182023-12-08
00196449002573LEOS Cannulated Screw System76312020763120202023-12-08
00196449002580LEOS Cannulated Screw System76312022763120222023-12-08
00196449002597LEOS Cannulated Screw System76312024763120242023-12-08
00196449002603LEOS Cannulated Screw System76312026763120262023-12-08
00196449002610LEOS Cannulated Screw System76312028763120282023-12-08
00196449002627LEOS Cannulated Screw System76312030763120302023-12-08
00196449002634LEOS Cannulated Screw System76312508763125082023-12-08
00196449002641LEOS Cannulated Screw System76312510763125102023-12-08
00196449002658LEOS Cannulated Screw System76312512763125122023-12-08
00196449002665LEOS Cannulated Screw System76312514763125142023-12-08
00196449002672LEOS Cannulated Screw System76312516763125162023-12-08
00196449002689LEOS Cannulated Screw System76312518763125182023-12-08
00196449002696LEOS Cannulated Screw System76312520763125202023-12-08
00196449002702LEOS Cannulated Screw System76312522763125222023-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776407520MillenniumAvalign Technologies, Inc.HTZ2026-07-31
03701089527491AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527507AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527514AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527521AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527583AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527590AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527606AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527682AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527699AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527705AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527712AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527729AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527736AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527743AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527750AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527767AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527774AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527781AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527798AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527804AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527811AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527828AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527835AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527842AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527859AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089540780AMPLITUDEAMPLITUDE SASHTZ2026-07-29
00190776402129MillenniumAvalign Technologies, Inc.HTZ2026-07-19
M697X07901151Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.HTZ2026-07-08
10603295552390ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-05-18