FDA.reportPublic FDA data

Anatomic Access LLIF

Primary DI
00196449034550
Brand
Anatomic Access LLIF
Company
Tyber Medical, LLC
Model
NAV81290000
Device description
NAV, Anatomic Access LLIF, Osteotome
Published
2025-11-25
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
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252742000Navigated InstrumentsTyber Medical, LLC2025-10-28OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196449034550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449034550001964490345501964490345500196449034550

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. 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, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. 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)761-0933regulatory@exalta.com

Regulatory Flags#

DUNS number
010968002
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00196449017348A.L.P.S. mvX™770001151A2026-06-04
00196449017355A.L.P.S. mvX™770002250A2026-06-04
00196449017362A.L.P.S. mvX™770002251A2026-06-04
00196449017379A.L.P.S. mvX™770001060A2026-06-04
00196449017386A.L.P.S. mvX™770001080A2026-06-04
00196449017393A.L.P.S. mvX™770001150A2026-06-04
00196449017409A.L.P.S. mvX™770002151A2026-06-04
00196449017416A.L.P.S. mvX™770002181A2026-06-04
00196449017423A.L.P.S. mvX™770002182A2026-06-04
00196449017430A.L.P.S. mvX™770002200A2026-06-04
00196449017447A.L.P.S. mvX™770002201A2026-06-04
00196449017454A.L.P.S. mvX™770001040A2026-06-04
00196449017461A.L.P.S. mvX™770002090A2026-06-04
00196449017478A.L.P.S. mvX™770002100A2026-06-04
00196449017485A.L.P.S. mvX™770002150A2026-06-04
00196449017492A.L.P.S. mvX™770002180A2026-06-04
00196449017508A.L.P.S. mvX™770003200A2026-06-04
00196449017515A.L.P.S. mvX™770003240A2026-06-04
00196449017522A.L.P.S. mvX™770003270A2026-06-04
00196449017539A.L.P.S. mvX™770003350A2026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422664RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422671RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422688RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422695RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422701RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422718RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422770RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422787RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422794RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422800RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422817RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422824RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422831RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422848RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422855RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422862RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422879RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422886RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05