SeaSpine Spacer System - Pacifica™ 33-5614

GUDID 10889981032043

Pacifica Implant 9mm x 24mm x 14mm, Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile
Primary Device ID10889981032043
NIH Device Record Key0b5c276e-79f6-4272-b055-6da7138508db
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeaSpine Spacer System - Pacifica™
Version Model Number33-5614
Catalog Number33-5614
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
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
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
GS110889981032043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981032043]

Moist Heat or Steam Sterilization


[10889981032043]

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 [SeaSpine Spacer System - Pacifica™]

10889981058906Pacifica Trial, 9mm x 24mm x 18mm
10889981058890Pacifica Trial, 9mm x 24mm x 17mm
10889981058883Pacifica Trial, 9mm x 24mm x 16mm
10889981058876Pacifica Trial, 9mm x 24mm x 15mm
10889981058869Pacifica Trial, 9mm x 24mm x 14mm
10889981058852Pacifica Trial, 9mm x 24mm x 13mm
10889981058845Pacifica Trial, 9mm x 24mm x 12mm
10889981058838Pacifica Trial, 9mm x 24mm x 11mm
10889981058821Pacifica Trial, 9mm x 24mm x 10mm
10889981058814Pacifica Trial, 9mm x 24mm x 9mm
10889981058807Pacifica Trial, 9mm x 24mm x 8mm
10889981058791Pacifica Trial, 9mm x 24mm x 7mm
10889981058784Pacifica Trial, 9mm x 20mm x 18mm
10889981058777Pacifica Trial, 9mm x 20mm x 17mm
10889981058760Pacifica Trial, 9mm x 20mm x 16mm
10889981058753Pacifica Trial, 9mm x 20mm x 15mm
10889981058746Pacifica Trial, 9mm x 20mm x 14mm
10889981058739Pacifica Trial, 9mm x 20mm x 13mm
10889981058722Pacifica Trial, 9mm x 20mm x 12mm
10889981058715Pacifica Trial, 9mm x 20mm x 11mm
10889981058708Pacifica Trial, 9mm x 20mm x 10mm
10889981058692Pacifica Trial, 9mm x 20mm x 9mm
10889981058685Pacifica Trial, 9mm x 20mm x 8mm
10889981058678Pacifica Trial, 9mm x 20mm x 7mm
10889981058661Pacifica-S Implant, 9mm x 24mm x 18mm
10889981058654Pacifica-S Implant, 9mm x 24mm x 17mm
10889981058647Pacifica-S Implant, 9mm x 24mm x 16mm
10889981058630Pacifica-S Implant, 9mm x 24mm x 15mm
10889981058623Pacifica-S Implant, 9mm x 24mm x 14mm
10889981058616Pacifica-S Implant, 9mm x 24mm x 13mm
10889981058609Pacifica-S Implant, 9mm x 24mm x 12mm
10889981058593Pacifica-S Implant, 9mm x 24mm x 11mm
10889981058586Pacifica-S Implant, 9mm x 24mm x 10mm
10889981058579Pacifica-S Implant, 9mm x 24mm x 9mm
10889981058562Pacifica-S Implant, 9mm x 24mm x 8mm
10889981058555Pacifica-S Implant, 9mm x 24mm x 7mm
10889981058548Pacifica-S Implant, 9mm x 20mm x 18mm
10889981058531Pacifica-S Implant, 9mm x 20mm x 17mm
10889981058524Pacifica-S Implant, 9mm x 20mm x 16mm
10889981058517Pacifica-S Implant, 9mm x 20mm x 15mm
10889981058500Pacifica-S Implant, 9mm x 20mm x 14mm
10889981058494Pacifica-S Implant, 9mm x 20mm x 13mm
10889981058487Pacifica-S Implant, 9mm x 20mm x 12mm
10889981058470Pacifica-S Implant, 9mm x 20mm x 11mm
10889981058463Pacifica-S Implant, 9mm x 20mm x 10mm
10889981058456Pacifica-S Implant, 9mm x 20mm x 9mm
10889981058449Pacifica-S Implant, 9mm x 20mm x 8mm
10889981058432Pacifica-S Implant, 9mm x 20mm x 7mm
10889981032951Pacifica Trial 9mm x 24mm x 17mm, Lordotic
10889981032937Pacifica Trial 9mm x 24mm x 15mm, Lordotic

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