FDA.reportPublic FDA data

Anatomic Access LLIF

Primary DI
00196449034307
Brand
Anatomic Access LLIF
Company
Tyber Medical, LLC
Model
NAV81190000
Device description
NAV, Anatomic Access LLIF, Rasp, In-Line
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
00196449034307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449034307001964490343071964490343070196449034307

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
00196449033393A.L.P.S. mvX™7701030902026-07-23
00196449033409A.L.P.S. mvX™7701070902026-07-23
00196449011735A.L.P.S. mvX™7703000407703000402024-01-20
00196449011742A.L.P.S. mvX™7703000457703000452024-01-20
00196449011759A.L.P.S. mvX™7703000507703000502024-01-20
00196449011766A.L.P.S. mvX™7703000557703000552024-01-20
00196449011773A.L.P.S. mvX™7703000607703000602024-01-20
00196449011780A.L.P.S. mvX™7703000707703000702024-01-20
00196449011797A.L.P.S. mvX™7703520407703520402024-01-20
00196449011803A.L.P.S. mvX™7703520457703520452024-01-20
00196449011810A.L.P.S. mvX™7703520507703520502024-01-20
00196449011827A.L.P.S. mvX™7703520557703520552024-01-20
00196449011834A.L.P.S. mvX™7703520607703520602024-01-20
00196449011841A.L.P.S. mvX™7703520707703520702024-01-20
00196449011858A.L.P.S. mvX™7704010407704010402024-01-20
00196449011865A.L.P.S. mvX™7704010457704010452024-01-20
00196449011872A.L.P.S. mvX™7704010507704010502024-01-20
00196449011889A.L.P.S. mvX™7704010557704010552024-01-20
00196449011896A.L.P.S. mvX™7704010607704010602024-01-20
00196449011902A.L.P.S. mvX™7704010707704010702024-01-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCOLO2026-07-23
00840466901035PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901615PrimusSPINAL ELEMENTS, INC.OLO2026-07-21