Zuma-C™ 57-2309

GUDID 10889981053116

Zuma-C Implant, 13x12x9mm

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile Vertebral body prosthesis, non-sterile
Primary Device ID10889981053116
NIH Device Record Key85c1a227-6b8e-4550-8383-b084e72b99b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameZuma-C™
Version Model Number57-2309
Catalog Number57-2309
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(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981053116 [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

[10889981053116]

Moist Heat or Steam Sterilization

[10889981053116]

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 [Zuma-C™]

10889981062507Zuma-C Implant
10889981062491Zuma-C 17mm Implant
10889981054021Self-Drilling Variable Bone Screw, Single Lead, 4.0 x 20mm
10889981054014Self-Drilling Variable Bone Screw, Single Lead, 4.0 x 18mm
10889981054007Self-Drilling Variable Bone Screw, Single Lead, 4.0 x 16mm
10889981053994Self-Drilling Variable Bone Screw, Single Lead, 4.0 x 14mm
10889981053987Self-Drilling Variable Bone Screw, Single Lead, 4.0 x 12mm
10889981053970Self-Drilling Variable Bone Screw, Single Lead, 4.0 x 10mm
10889981053963Zuma-C Trial, 17x12.5x12mm w/Stop
10889981053956Zuma-C Trial, 17x12.5x11mm w/Stop
10889981053949Zuma-C Trial, 17x12.5x10mm w/Stop
10889981053932Zuma-C Trial, 17x12.5x9mm w/Stop
10889981053925Zuma-C Trial, 17x12.5x8mm w/Stop
10889981053918Zuma-C Trial, 17x12.5x7mm w/Stop
10889981053901Zuma-C Trial, 17x12.5x6mm w/Stop
10889981053895Zuma-C Trial, 17x13.5x12mm, Lordotic
10889981053888Zuma-C Trial, 17x13.5x11mm, Lordotic
10889981053871Zuma-C Trial, 17x13.5x10mm, Lordotic
10889981053864Zuma-C Trial, 17x13.5x9mm, Lordotic
10889981053857Zuma-C Trial, 17x13.5x8mm, Lordotic
10889981053840Zuma-C Trial, 17x13.5x7mm, Lordotic
10889981053833Zuma-C Trial, 17x13.5x6mm, Lordotic
10889981053826Zuma-C Trial, 15x12x12mm w/Stop
10889981053819Zuma-C Trial, 15x12x11mm w/Stop
10889981053802Zuma-C Trial, 15x12x10mm w/Stop
10889981053796Zuma-C Trial, 15x12x9mm w/Stop
10889981053789Zuma-C Trial, 15x12x8mm w/Stop
10889981053772Zuma-C Trial, 15x12x7mm w/Stop
10889981053765Zuma-C Trial, 15x12x6mm w/Stop
10889981053758Zuma-C Trial, 15x13x12mm, Lordotic
10889981053741Zuma-C Trial, 15x13x11mm, Lordotic
10889981053734Zuma-C Trial, 15x13x10mm, Lordotic
10889981053727Zuma-C Trial, 15x13x9mm, Lordotic
10889981053710Zuma-C Trial, 15x13x8mm, Lordotic
10889981053703Zuma-C Trial, 15x13x7mm, Lordotic
10889981053697Zuma-C Trial, 15x13x6mm, Lordotic
10889981053680Zuma-C Trial, 13x12x12mm w/Stop
10889981053673Zuma-C Trial, 13x12x11mm w/Stop
10889981053666Zuma-C Trial, 13x12x10mm w/Stop
10889981053659Zuma-C Trial, 13x12x9mm w/Stop
10889981053642Zuma-C Trial, 13x12x8mm w/Stop
10889981053635Zuma-C Trial, 13x12x7mm w/Stop
10889981053628Zuma-C Trial, 13x12x6mm w/Stop
10889981053611Zuma-C Trial, 13x12x12mm, Lordotic
10889981053604Zuma-C Trial, 13x12x11mm, Lordotic
10889981053598Zuma-C Trial, 13x12x10mm, Lordotic
10889981053581Zuma-C Trial, 13x12x9mm, Lordotic
10889981053574Zuma-C Trial, 13x12x8mm, Lordotic
10889981053567Zuma-C Trial, 13x12x7mm, Lordotic
10889981053550Zuma-C Trial, 13x12x6mm, Lordotic
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