FDA.reportPublic FDA data

Kitsune

Primary DI
M9702800020180
Brand
Kitsune
Company
Medshape, Inc.
Model
2800-02-018
Device description
18mm Staple Drill Guide, reusable, Kitsune
Published
2017-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXIGuide, Drill, Ligament

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXIGuide, Drill, LigamentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9702800020180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
601306413
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
00190446907466EF1916-07-00012026-06-25
00190446907473EF1916-07-00022026-06-25
M97015000009200Eclipse1500-00-09202017-02-16
M97015000004100Eclipse1500-00-04102017-05-19
M97015000004170Eclipse1500-00-04172017-02-16
M97015000005120Eclipse1500-00-05122017-05-19
M97015000005200Eclipse1500-00-05202017-05-19
M97015000006200Eclipse1500-00-06202017-05-19
M97015000007200Eclipse1500-00-07202017-05-19
M97015000008200Eclipse1500-00-08202017-05-19
00190446914020EF1DNE-1000-WFB32026-04-01
00190446914563EF1DNE-6000-0402026-04-01
00190446907374EF1911-07-00012026-03-31
00190446907381EF1911-07-00022026-03-31
00190446907404EF1912-07-00012026-03-31
00190446907411EF1912-07-00022026-03-31
00190446908333EF1913-07-00012026-03-31
00190446908340EF1913-07-00022026-03-31
00190446908357EF1913-07-00032026-03-31
00190446908364EF1913-07-00042026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00888867500907Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500938Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500976Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500990Arthrex®ARTHREX, INC.LXI2026-03-13
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00840124519978PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124519985PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520189PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520226PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520233PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520257PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520264PolyLock AnkleFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520325PolyLock AnkleFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520332PolyLock AnkleFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124519572PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519589PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519602PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519619PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519664PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519671PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519688PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519695PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519701PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519732PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519787PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519794PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519800PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519831PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15