FDA.reportPublic FDA data

NA

Primary DI
08800048442150
Brand
NA
Company
Medyssey Co., Ltd.
Model
NAFI-105
Device description
Final Impactor (ALIF)
Published
2025-02-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800048442150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800048442150088000484421508800048442150

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688211503
Device count
1
Premarket exempt
true
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
08800311596863NAPNPS-0032026-03-12
08800311596696NANNSS-0022026-03-09
08800311596665NANXVC-0022026-02-19
08800311596474Medyssey Poseidon OCT Spinal Fixation SystemR350552026-01-30
08800311596481Medyssey Poseidon OCT Spinal Fixation SystemR350652026-01-30
08800311596498Medyssey Poseidon OCT Spinal Fixation SystemR350752026-01-30
08800311596504Medyssey Poseidon OCT Spinal Fixation SystemR350852026-01-30
08800311596511Medyssey Poseidon OCT Spinal Fixation SystemR350952026-01-30
08800311596528Medyssey Poseidon OCT Spinal Fixation SystemR351052026-01-30
08800311596535Medyssey Poseidon OCT Spinal Fixation SystemR351152026-01-30
08800311596542Medyssey Poseidon OCT Spinal Fixation SystemR351252026-01-30
08800311596559Medyssey Poseidon OCT Spinal Fixation SystemR351352026-01-30
08800311596566Medyssey Poseidon OCT Spinal Fixation SystemR351452026-01-30
08800311596573Medyssey Poseidon OCT Spinal Fixation SystemR351552026-01-30
08800311596580Medyssey Poseidon OCT Spinal Fixation SystemR351652026-01-31
08800311596597Medyssey Poseidon OCT Spinal Fixation SystemR351752026-01-30
08800311596603Medyssey Poseidon OCT Spinal Fixation SystemR351852026-01-30
08800311596610Medyssey Poseidon OCT Spinal Fixation SystemR351952026-01-30
08800048442204NANABP-0012025-02-26
08800042416423NANGIP-C012023-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889795155856APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-09-29
00889795155863APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-09-29
07899258696058Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
07901125621138Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
07901125621145Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
07901125621312Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
07901125621329Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
07901125621336Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
07901125621350Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
07901125621398Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
07630542794964Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542794971Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542794988Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542794995Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795343Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795350Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795442Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795459Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795541Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795640Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795657Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795718Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795725Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795732Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795893Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542797262Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542797279Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542797286Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542799723Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542799754Surgical Manual InstrumentMedacta International SALXH2026-09-28