FDA.reportPublic FDA data

Navagio

Primary DI
B07330K0142140
Brand
Navagio
Company
Kalitec Direct LLC
Model
30-K01-4214
Catalog number
30-K01-4214
Device description
Trial, TLIF, 32L OB CRV 7Deg, 14mm
Published
2022-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07330K0142140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
041956211
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B073DRK0100300CosmolockDR-K01-0030DR-K01-00302021-03-16
B073K0730000Matira07-K07-300007-K07-30002020-01-03
B07307CPR01181Matira Anterior Cervical Plate System07-CPR-011807-CPR-01182017-10-31
B07307CPR01191MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-011907-CPR-01192017-10-31
B07307CPR01201MATIRA ANTERIOR CERVICAL PLATE SYSTEM07-CPR-012007-CPR-01202017-10-31
B07307CPR01211MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-012101-CPR-01212017-10-31
B07307CPR01221MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-012207-CPR-01222017-10-31
B07307CPR01241MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-012407-CPR-01242017-10-31
B07307CPR01261MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-012607-CPR-01262017-10-31
B07307CPR01281MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-012807-CPR-01282017-10-31
B07307CPR01301MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-013007-CPR-01302017-10-31
B07307CPR01321MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-013207-CPR-01322017-10-31
B07307CPR01341MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-013407-CPR-01342017-10-31
B07307CPR02321MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-023207-CPR-02322017-10-31
B07307CPR02341MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-023407-CPR-02342017-10-31
B07307CPR02361MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-023607-CPR-02362017-10-31
B07307CPR02381MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-023807-CPR-02382017-10-31
B07307CPR02401MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-024007-CPR-02402017-10-31
B07307CPR02421MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-024207-CPR-02422017-10-31
B07307CPR02441MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-024407-CPR-02442017-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G079INL1160070Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
G079INL1160120Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
08806373887772BENCOX Surgical InstrumentsCorentec Co., LtdFZX2026-01-12
08800089479375Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2025-12-04
07640332475348CURE 2.0 ACPSpineArt SAFZX2025-11-12
07640375235732PERLA ® TL MISSpineArt SAFZX2025-11-10
G79153202001620G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
G79153202021615G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
08800071017462Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017479Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017486Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017493Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017509Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017516Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017523Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084389Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084396Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084402Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084419Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084426Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084433Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
G463090799PK0Spine InstrumentsBOXSPINE HOLDINGS, INC.FZX2025-01-16
08800089436033Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436040Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436057Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436064Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436071Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436088Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436095Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436101Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17