Complete Cervical 27-11-3515

GUDID 10889981040611

Screw - Self-Tapping - 3.5x15mm

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile Vertebral body prosthesis, non-sterile
Primary Device ID10889981040611
NIH Device Record Key5df339df-59f4-4e4f-bbc9-4afcbb5b4a18
Commercial Distribution Discontinuation2016-09-02
Commercial Distribution StatusNot in Commercial Distribution
Brand NameComplete Cervical
Version Model Number27-11-3515
Catalog Number27-11-3515
Company DUNS079840876
Company NameSEASPINE ORTHOPEDICS CORPORATION
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 Usefalse
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(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981040611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981040611]

Moist Heat or Steam Sterilization

[10889981040611]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [Complete Cervical]

10889981041113Screw Self-Drilling - 4.0x19mm
10889981041106Screw Self-Drilling - 4.0x17mm
10889981041090Screw Self-Drilling - 4.0x15mm
10889981041083Screw Self-Drilling - 4.0x13mm
10889981041076Screw Self-Drilling - 4.0x11mm
10889981041069Screw - Self-Drilling - 3.5x18mm
10889981041052Screw - Self-Drilling - 3.5x17mm
10889981041045Screw - Self-Drilling - 3.5x16mm
10889981041038Screw - Self-Drilling - 3.5x15mm
10889981041021Screw - Self-Drilling - 3.5x14mm
10889981041014Screw - Self-Drilling - 3.5x13mm
10889981041007Screw - Self-Drilling - 3.5x12mm
10889981040994Screw - Self-Drilling - 3.5x11mm
10889981040987Screw - Self-Drilling - 3.5x10mm
10889981040970Screw Self-Tapping - 4.0x19mm
10889981040963Screw Self-Tapping - 4.0x17mm
10889981040956Screw Self-Tapping - 4.0x15mm
10889981040949Screw Self-Tapping - 4.0x13mm
10889981040932Screw Self-Tapping - 4.0x11mm
10889981040925Screw - Self-Tapping - 3.5x18mm
10889981040918Screw - Self-Tapping - 3.5x17mm
10889981040901Screw - Self-Tapping - 3.5x16mm
10889981040895Screw - Self-Tapping - 3.5x15mm
10889981040888Screw - Self-Tapping - 3.5x14mm
10889981040871Screw - Self Tapping - 3.5x13mm
10889981040864Screw - Self-Tapping - 3.5x12mm
10889981040857Screw - Self-Tapping - 3.5x11mm
10889981040840Screw - Self-Tapping - 3.5x10mm
10889981040833Screw Self-Drilling - 4.0x19mm
10889981040826Screw Self-Drilling - 4.0x17mm
10889981040819Screw Self-Drilling - 4.0x15mm
10889981040802Screw Self-Drilling - 4.0x13mm
10889981040796Screw Self-Drilling - 4.0x11mm
10889981040789Screw - Self-Drilling - 3.5x18mm
10889981040772Screw - Self-Drilling - 3.5x17mm
10889981040765Screw - Self-Drilling - 3.5x16mm
10889981040758Screw - Self-Drilling - 3.5x15mm
10889981040741Screw - Self-Drilling - 3.5x14mm
10889981040734Screw - Self-Drilling - 3.5x13mm
10889981040727Screw - Self-Drilling - 3.5x12mm
10889981040710Screw - Self-Drilling - 3.5x11mm
10889981040703Screw - Self-Drilling - 3.5x10mm
10889981040697Screw Self-Tapping - 4.0x19mm
10889981040680Screw Self-Tapping - 4.0x17mm
10889981040673Screw Self-Tapping - 4.0x15mm
10889981040666Screw Self-Tapping - 4.0x13mm
10889981040659Screw Self-Tapping - 4.0x11mm
10889981040642Screw - Self-Tapping - 3.5x18mm
10889981040635Screw - Self-Tapping - 3.5x17mm
10889981040628Screw - Self-Tapping - 3.5x16mm
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