Zuma-C 57-1711

GUDID 10889981076450

Zuma-C Implant, 17 x 13.5 x 11mm, Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile Vertebral body prosthesis, non-sterile
Primary Device ID10889981076450
NIH Device Record Key70085f33-e1a6-4675-aee5-a4c6cff70a18
Commercial Distribution StatusIn Commercial Distribution
Brand NameZuma-C
Version Model Number57-1711
Catalog Number57-1711
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
GS110889981076450 [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

[10889981076450]

Moist Heat or Steam Sterilization

[10889981076450]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-12-22

On-Brand Devices [Zuma-C]

10889981120733Zuma-C Universal Graft Packing Block
10889981120177Zuma-C Implant, 17 x 13.5 x 12mm, Lordotic
10889981100414Zuma-C Locking Cover Caddy
10889981100407Zuma-C Implant Caddy, 17 x 12.5mm
10889981100391Zuma-C Implant Caddy, 15 x 12mm
10889981100384Zuma-C Implant Caddy, 13 x 12mm
10889981100377Zuma-C Implant and Instrument Tray
10889981100360Zuma-C 17mm Implant and Trial Tray
10889981100353Zuma-C AIO Guide Tip Caddy
10889981100346Zuma-C Locking Cap Caddy
10889981100339Zuma-C Implant Caddy, 17 x 13.5mm
10889981100322Zuma-C Implant Caddy, 15 x 13mm
10889981100315Zuma-C Implant Caddy, 13 x 12mm
10889981100308Zuma-C Implant and Instrument Tray
10889981100292Zuma-C Rasp, 13x12x12mm, Lordotic
10889981100285Zuma-C Rasp, 13x12x11mm, Lordotic
10889981100278Zuma-C Rasp, 13x12x10mm, Lordotic
10889981100261Zuma-C Rasp, 13x12x9mm, Lordotic
10889981100254Zuma-C Rasp, 13x12x8mm, Lordotic
10889981100247Zuma-C Rasp, 13x12x7mm, Lordotic
10889981100230Zuma-C Rasp, 13x12x6mm, Lordotic
10889981100223Graft Packing Block
10889981100216Zuma-C Graft Tamp
10889981100193Zuma-C Drill, 18mm
10889981100186Zuma-C Drill, 16mm
10889981100179Zuma-C Drill, 14mm
10889981100162Zuma-C Drill, 12mm
10889981100155Zuma-C Drill, 10mm
10889981100148Freehand Drill Guide, Extended
10889981100131Freehand Drill Guide
10889981100124AIO Guide, 12 Deg
10889981100117Plate Removal Tool
10889981100100Screw Extracter, 2.5mm Hex
10889981100094Locking Cover Extractor, 2.0mm Hex
10889981100087Locking Cover Driver Shaft, Self Retaining
10889981100070Torque Limiting Handle, 5 in-lbs
10889981100063Distraction Pin Template
10889981100056Zuma-C Awl
10889981100049Zuma-C Implant Inserter
10889981100032AIO Guide Tip, 12mm
10889981100025AIO Guide Tip, 11mm
10889981100018AIO Guide Tip, 10mm
10889981100001AIO Guide Tip, 9mm
10889981099992AIO Guide Tip, 8mm
10889981099985AIO Guide Tip, 7mm
10889981099978AIO Guide Tip, 6mm
10889981099961AIO Guide Handle
10889981099954Implant Tamp
10889981099947Zuma-C Inserter Shaft, Extended
10889981099930Zuma-C Inserter
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