SeaSpine Spacer System - Pacifica 33-5210

GUDID 10889981031794

Pacifica Implant 9mm x 20mm x 10mm, Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile Vertebral body prosthesis, non-sterile
Primary Device ID10889981031794
NIH Device Record Key2a3a33c9-8152-4cb0-9fe1-9b13df60bbb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeaSpine Spacer System - Pacifica
Version Model Number33-5210
Catalog Number33-5210
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 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(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
GS110889981031794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981031794]

Moist Heat or Steam Sterilization

[10889981031794]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-02

On-Brand Devices [SeaSpine Spacer System - Pacifica]

10889981162214Pacifica 9x20mm, Lordotic Implants
10889981162207Pacifica 11x24mm Implants
10889981162191Pacifica 11x20mm Implants
10889981120368Paddle Scraper, Long, Convex, 18mm
10889981120351Bullet Distractor, 18mm
10889981120344Graft Tamp
10889981089566Paddle Scraper, Long, Convex, 17mm
10889981089559Paddle Scraper, Long, Convex, 16mm
10889981089542Paddle Scraper, Long, Convex, 15mm
10889981089535Paddle Scraper, Long, Convex, 14mm
10889981089528Paddle Scraper, Long, Convex, 13mm
10889981089511Paddle Scraper, Long, Convex, 12mm
10889981089504Paddle Scraper, Long, Convex, 11mm
10889981089498Paddle Scraper, Long, Convex, 10mm
10889981089481Paddle Scraper, Long, Convex, 9mm
10889981089474Paddle Scraper, Long, Convex, 8mm
10889981089467Paddle Scraper, Long, Convex, 7mm
10889981089450Long Bullet Distractor, 18mm
10889981089443Long Bullet Distractor, 17mm
10889981089436Long Bullet Distractor, 16mm
10889981089429Long Bullet Distractor, 15mm
10889981089412Long Bullet Distractor, 14mm
10889981089405Long Bullet Distractor, 13mm
10889981089399Long Bullet Distractor, 12mm
10889981089382Long Bullet Distractor, 11mm
10889981089375Long Bullet Distractor, 10mm
10889981089368Long Bullet Distractor, 9mm
10889981089351Long Bullet Distractor, 8mm
10889981089344Long Bullet Distractor, 7mm
10889981089337Paddle Scraper, Convex, 18mm
10889981089320Paddle Scraper, Convex, 17mm
10889981089313Paddle Scraper, Convex, 16mm
10889981089306Paddle Scraper, Convex, 15mm
10889981089290Paddle Scraper, Convex, 14mm
10889981089283Paddle Scraper, Convex, 13mm
10889981089276Paddle Scraper, Convex, 12mm
10889981089269Paddle Scraper, Convex, 11mm
10889981089252Paddle Scraper, Convex, 10mm
10889981089245Paddle Scraper, Convex, 9mm
10889981089238Paddle Scraper, Convex, 8mm
10889981089221Paddle Scraper, Convex, 7mm
10889981089153Pacifica/Ventura Hybrid IMP and Instrument Tray
10889981089122Pacifica Implant Caddy Lid 11mm x 24mm Lordotic
10889981089115Pacifica Implant Caddy Lid - 9mm x 24mm Lordotic
10889981089108Pacifica Implant Caddy Lid 11mm x 20mm Lordotic
10889981089092Pacifica Implant Caddy Lid - 9mm x 20mm Lordotic
10889981089085Pacifica Implant Caddy Lid - 11mm x 24mm
10889981089078Pacifica Implant Caddy Lid - 9mm x 24mm
10889981089061Pacifica Implant Caddy Lid - 11mm x 20mm
10889981089054Pacifica Implant Caddy Lid - 9mm x 20mm
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