ANODYNE Plate System 20004-088

GUDID M72520004088

ANODYNE CERVICAL PLATE - 4 LEVEL, 88MM

CORELINK LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device IDM72520004088
NIH Device Record Key90032503-5602-484e-a2e1-27aaf41d8faf
Commercial Distribution StatusIn Commercial Distribution
Brand NameANODYNE Plate System
Version Model Number20004-088
Catalog Number20004-088
Company DUNS064191453
Company NameCORELINK LLC
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

Customer Support Contacts

Phone+1(314)863-5401
Emailcustomer.service@corelinksurgical.com
Phone+1(314)863-5401
Emailcustomer.service@corelinksurgical.com
Phone+1(314)863-5401
Emailcustomer.service@corelinksurgical.com
Phone+1(314)863-5401
Emailcustomer.service@corelinksurgical.com
Phone+1(314)863-5401
Emailcustomer.service@corelinksurgical.com
Phone+1(314)863-5401
Emailcustomer.service@corelinksurgical.com
Phone+1(314)863-5401
Emailcustomer.service@corelinksurgical.com
Phone+1(314)863-5401
Emailcustomer.service@corelinksurgical.com
Phone+1(314)863-5401
Emailcustomer.service@corelinksurgical.com
Phone+1(314)863-5401
Emailcustomer.service@corelinksurgical.com
Phone+1(314)863-5401
Emailcustomer.service@corelinksurgical.com
Phone+1(314)863-5401
Emailcustomer.service@corelinksurgical.com
Phone+1(314)863-5401
Emailcustomer.service@corelinksurgical.com
Phone+1(314)863-5401
Emailcustomer.service@corelinksurgical.com
Phone+1(314)863-5401
Emailcustomer.service@corelinksurgical.com

Device Dimensions

Height88 Millimeter
Height88 Millimeter
Height88 Millimeter
Height88 Millimeter
Height88 Millimeter
Height88 Millimeter
Height88 Millimeter
Height88 Millimeter
Height88 Millimeter
Height88 Millimeter
Height88 Millimeter
Height88 Millimeter
Height88 Millimeter
Height88 Millimeter
Height88 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM72520004088 [Primary]

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M72520004088]

Moist Heat or Steam Sterilization


[M72520004088]

Moist Heat or Steam Sterilization


[M72520004088]

Moist Heat or Steam Sterilization


[M72520004088]

Moist Heat or Steam Sterilization


[M72520004088]

Moist Heat or Steam Sterilization


[M72520004088]

Moist Heat or Steam Sterilization


[M72520004088]

Moist Heat or Steam Sterilization


[M72520004088]

Moist Heat or Steam Sterilization


[M72520004088]

Moist Heat or Steam Sterilization


[M72520004088]

Moist Heat or Steam Sterilization


[M72520004088]

Moist Heat or Steam Sterilization


[M72520004088]

Moist Heat or Steam Sterilization


[M72520004088]

Moist Heat or Steam Sterilization


[M72520004088]

Moist Heat or Steam Sterilization


[M72520004088]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-12-04
Device Publish Date2016-01-21

On-Brand Devices [ANODYNE Plate System]

M7252145220ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF TAPPING - 5.2MM X 20MM
M7252145218ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF TAPPING - 5.2MM X 18MM
M7252145216ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF TAPPING - 5.2MM X 16MM
M7252145214ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF TAPPING - 5.2MM X 14MM
M7252145212ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF TAPPING - 5.2MM X 12MM
M7252144620ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF TAPPING - 4.6MM X 20MM
M7252144618ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF TAPPING - 4.6MM X 18MM
M7252144616ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF TAPPING - 4.6MM X 16MM
M7252144614ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF TAPPING - 4.6MM X 14MM
M7252144612ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF TAPPING - 4.6MM X 12MM
M7252135220ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF DRILLING - 5.2MM X 20MM
M7252135218ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF DRILLING - 5.2MM X 18MM
M7252135216ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF DRILLING - 5.2MM X 16MM
M7252135214ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF DRILLING - 5.2MM X 14MM
M7252135212ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF DRILLING - 5.2MM X 12MM
M7252134620ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF DRILLING - 4.6MM X 20MM
M7252134618ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF DRILLING - 4.6MM X 18MM
M7252134616ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF DRILLING - 4.6MM X 16MM
M7252134614ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF DRILLING - 4.6MM X 14MM
M7252134612ANODYNE-SINGLE CERVICAL SCREW - FIXED SELF DRILLING - 4.6MM X 12MM
M7252125220ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF TAPPING - 5.2MM X 20MM
M7252125218ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF TAPPING - 5.2MM X 18MM
M7252125216ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF TAPPING - 5.2MM X 16MM
M7252125214ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF TAPPING - 5.2MM X 14MM
M7252125212ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF TAPPING - 5.2MM X 12MM
M7252124620ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF TAPPING - 4.6MM X 20MM
M7252124618ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF TAPPING - 4.6MM X 18MM
M7252124616ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF TAPPING - 4.6MM X 16MM
M7252124614ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF TAPPING - 4.6MM X 14MM
M7252124612ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF TAPPING - 4.6MM X 12MM
M7252115220ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF DRILLING - 5.2MM X 20MM
M7252115218ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF DRILLING - 5.2MM X 18MM
M7252115216ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF DRILLING - 5.2MM X 16MM
M7252115214ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF DRILLING - 5.2MM X 14MM
M7252115212ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF DRILLING - 5.2MM X 12MM
M7252114620ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF DRILLING - 4.6MM X 20MM
M7252114618ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF DRILLING - 4.6MM X 18MM
M7252114616ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF DRILLING - 4.6MM X 16MM
M7252114614ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF DRILLING - 4.6MM X 14MM
M7252114612ANODYNE-SINGLE CERVICAL SCREW - VARIABLE SELF DRILLING - 4.6MM X 12MM
M72521002040ANODYNE-SINGLE CERVICAL PLATE - 2 LEVEL, 40MM
M72521002038ANODYNE-SINGLE CERVICAL PLATE - 2 LEVEL, 38MM
M72521002036ANODYNE-SINGLE CERVICAL PLATE - 2 LEVEL, 36MM
M72521002034ANODYNE-SINGLE CERVICAL PLATE - 2 LEVEL, 34MM
M72521002032ANODYNE-SINGLE CERVICAL PLATE - 2 LEVEL, 32MM
M72521002030ANODYNE-SINGLE CERVICAL PLATE - 2 LEVEL, 30MM
M72521002028ANODYNE-SINGLE CERVICAL PLATE - 2 LEVEL, 28MM
M72521002026ANODYNE-SINGLE CERVICAL PLATE - 2 LEVEL, 26MM
M72521001022ANODYNE-SINGLE CERVICAL PLATE - 1 LEVEL, 22MM
M72521001020ANODYNE-SINGLE CERVICAL PLATE - 1 LEVEL, 20MM

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.