CastleLoc-P Anterior Cervical Plate System

GUDID 08809649612061

CastleLoc-P Anterior Cervical Plate Screw(Self Drilling, Variable, Star) 3.5x12mm 1EA

L&K BIOMED CO. ,LTD.

Spinal fixation plate, non-bioabsorbable
Primary Device ID08809649612061
NIH Device Record Keyb09b9123-9035-466e-a30e-d037cb2ef466
Commercial Distribution StatusIn Commercial Distribution
Brand NameCastleLoc-P Anterior Cervical Plate System
Version Model Number6608-3512S
Company DUNS631159324
Company NameL&K BIOMED CO. ,LTD.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809649612061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-04
Device Publish Date2019-03-27

On-Brand Devices [CastleLoc-P Anterior Cervical Plate System]

08809649610654CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Variable, Star) 3.5x11mm 1EA
08809649610647CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Variable, Star) 3.5x10mm 1EA
08809649610630CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x22mm 1EA
08809649610623CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x21mm 1EA
08809649610616CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x20mm 1EA
08809649610609CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x19mm 1EA
08809649610593CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x18mm 1EA
08809649610586CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x17mm 1EA
08809649610579CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x16mm 1EA
08809649610562CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x15mm 1EA
08809649610555CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x14mm 1EA
08809649610548CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x13mm 1EA
08809649610531CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x12mm 1EA
08809649610524CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x11mm 1EA
08809649610517CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x10mm 1EA
08809649610500CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x22mm 1EA
08809649610494CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x21mm 1EA
08809649610487CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x20mm 1EA
08809649610470CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x19mm 1EA
08809649610463CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x18mm 1EA
08809649610456CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x17mm 1EA
08809649610449CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x16mm 1EA
08809649610432CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x15mm 1EA
08809649610425CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x14mm 1EA
08809649610418CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x13mm 1EA
08809649610401CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x12mm 1EA
08809649610395CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x11mm 1EA
08809649610388CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x10mm 1EA
08809649610371CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 97mm 1EA
08809649610364CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 93mm 1EA
08809649610357CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 89mm 1EA
08809649610340CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 85mm 1EA
08809649610333CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 81mm 1EA
08809649610326CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 77mm 1EA
08809649610319CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 73mm 1EA
08809649610302CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 69mm 1EA
08809649610296CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 65mm 1EA
08809649610289CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 72mm 1EA
08809649610272CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 69mm 1EA
08809649610265CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 66mm 1EA
08809649610258CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 63mm 1EA
08809649610241CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 60mm 1EA
08809649610234CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 57mm 1EA
08809649610227CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 54mm 1EA
08809649610210CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 51mm 1EA
08809649610203CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 48mm 1EA
08809649610197CastleLoc-P Anterior Cervical Plate (2Level-Contour Type) 51mm 1EA
08809649610180CastleLoc-P Anterior Cervical Plate (2Level-Contour Type) 49mm 1EA
08809649610173CastleLoc-P Anterior Cervical Plate (2Level-Contour Type) 47mm 1EA
08809649610166CastleLoc-P Anterior Cervical Plate (2Level-Contour Type) 45mm 1EA
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