KASILOF Cervical Plate System

GUDID B644KCP15451180

KASILOF VA Self-Drilling Screw 4.5 x 18mm

AXIS360 SURGICAL, INCOPORATED

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB644KCP15451180
NIH Device Record Key08c5ea04-25ec-409f-b192-b4e2f5440e27
Commercial Distribution StatusIn Commercial Distribution
Brand NameKASILOF Cervical Plate System
Version Model NumberKCP1-545-118
Company DUNS081208474
Company NameAXIS360 SURGICAL, INCOPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB644KCP15451180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B644KCP15451180]

Moist Heat or Steam Sterilization


[B644KCP15451180]

Moist Heat or Steam Sterilization


[B644KCP15451180]

Moist Heat or Steam Sterilization


[B644KCP15451180]

Moist Heat or Steam Sterilization


[B644KCP15451180]

Moist Heat or Steam Sterilization


[B644KCP15451180]

Moist Heat or Steam Sterilization


[B644KCP15451180]

Moist Heat or Steam Sterilization


[B644KCP15451180]

Moist Heat or Steam Sterilization


[B644KCP15451180]

Moist Heat or Steam Sterilization


[B644KCP15451180]

Moist Heat or Steam Sterilization


[B644KCP15451180]

Moist Heat or Steam Sterilization


[B644KCP15451180]

Moist Heat or Steam Sterilization


[B644KCP15451180]

Moist Heat or Steam Sterilization


[B644KCP15451180]

Moist Heat or Steam Sterilization


[B644KCP15451180]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-17
Device Publish Date2018-09-01

On-Brand Devices [KASILOF Cervical Plate System]

B644KCP15451180KASILOF VA Self-Drilling Screw 4.5 x 18mm
B644KCP15451160KASILOF VA Self-Drilling Screw 4.5 x 16mm
B644KCP15451140KASILOF VA Self-Drilling Screw 4.5 x 14mm
B644KCP15451120KASILOF VA Self-Drilling Screw 4.5 x 12mm
B644KCP15451100KASILOF VA Self-Drilling Screw 4.5 x 10mm
B644KCP15401180KASILOF VA Self-Drilling Screw 4.0 x 18mm
B644KCP15401160KASILOF VA Self-Drilling Screw 4.0 x 16mm
B644KCP15401140KASILOF VA Self-Drilling Screw 4.0 x 14mm
B644KCP15401120KASILOF VA Self-Drilling Screw 4.0 x 12mm
B644KCP15401100KASILOF VA Self-Drilling Screw 4.0 x 10mm
B644KCP15400180KASILOF VA Self-Tapping Screw 4.0 x 18mm
B644KCP15400160KASILOF VA Self-Tapping Screw 4.0 x 16mm
B644KCP15400140KASILOF VA Self-Tapping Screw 4.0 x 14mm
B644KCP15400120KASILOF VA Self-Tapping Screw 4.0 x 12mm
B644KCP15400100KASILOF VA Self-Tapping Screw 4.0 x 10mm
B644KCP14400180KASILOF FA Self-Tapping Screw 4.0 x 18mm
B644KCP14400160KASILOF FA Self-Tapping Screw 4.0 x 16mm
B644KCP14400140KASILOF FA Self-Tapping Screw 4.0 x 14mm
B644KCP14400120KASILOF FA Self-Tapping Screw 4.0 x 12mm
B644KCP14400100KASILOF FA Self-Tapping Screw 4.0 x 10mm
B644KCP13780KASILOF Cervical Plate 3 Level 78mm
B644KCP13750KASILOF Cervical Plate 3 Level 75mm
B644KCP13720KASILOF Cervical Plate 3 Level 72mm
B644KCP13690KASILOF Cervical Plate 3 Level 69mm
B644KCP13660KASILOF Cervical Plate 3 Level 66mm
B644KCP13630KASILOF Cervical Plate 3 Level 63mm
B644KCP13600KASILOF Cervical Plate 3 Level 60mm
B644KCP13570KASILOF Cervical Plate 3 Level 57mm
B644KCP13540KASILOF Cervical Plate 3 Level 54mm
B644KCP12550KASILOF Cervical Plate 2 Level 55mm
B644KCP12530KASILOF Cervical Plate 2 Level 53mm
B644KCP12510KASILOF Cervical Plate 2 Level 51mm
B644KCP12490KASILOF Cervical Plate 2 Level 49mm
B644KCP12470KASILOF Cervical Plate 2 Level 47mm
B644KCP12450KASILOF Cervical Plate 2 Level 45mm
B644KCP12430KASILOF Cervical Plate 2 Level 43mm
B644KCP12410KASILOF Cervical Plate 2 Level 41mm
B644KCP12390KASILOF Cervical Plate 2 Level 39mm
B644KCP12370KASILOF Cervical Plate 2 Level 37mm
B644KCP12350KASILOF Cervical Plate 2 Level 35mm
B644KCP11350KASILOF Cervical Plate 1 Level 35mm
B644KCP11330KASILOF Cervical Plate 1 Level 33mm
B644KCP11310KASILOF Cervical Plate 1 Level 31mm
B644KCP11290KASILOF Cervical Plate 1 Level 29mm
B644KCP11270KASILOF Cervical Plate 1 Level 27mm
B644KCP11250KASILOF Cervical Plate 1 Level 25mm
B644KCP11230KASILOF Cervical Plate 1 Level 23mm
B644KCP11210KASILOF Cervical Plate 1 Level 21mm
B644KCP11190KASILOF Cervical Plate 1 Level 19mm

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