SeaSpine Spacer System - Hollywood VI NanoMetalene 34-8116-S

GUDID 00889981034859

Hollywood VI NM Sterile 11mm x 27mm x 16mm, Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis
Primary Device ID00889981034859
NIH Device Record Key0b200bee-df08-40f1-8831-ab3914938d4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeaSpine Spacer System - Hollywood VI NanoMetalene
Version Model Number34-8116-S
Catalog Number34-8116-S
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 Datetrue
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889981034859 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-11-02

On-Brand Devices [SeaSpine Spacer System - Hollywood VI NanoMetalene]

00889981120095Hollywood VI NM Sterile 11mm x 30mm x 18mm, Lordotic
00889981064672Hollywood VI NM Sterile 11mm x 30mm x 17mm, Lordotic
00889981064665Hollywood VI NM Sterile 11mm x 30mm x 16mm, Lordotic
00889981064658Hollywood VI NM Sterile 11mm x 30mm x 15mm, Lordotic
00889981064641Hollywood VI NM Sterile 11mm x 30mm x 14mm, Lordotic
00889981064634Hollywood VI NM Sterile 11mm x 30mm x 13mm, Lordotic
00889981064627Hollywood VI NM Sterile 11mm x 30mm x 12mm, Lordotic
00889981064610Hollywood VI NM Sterile 11mm x 30mm x 11mm, Lordotic
00889981064603Hollywood VI NM Sterile 11mm x 30mm x 10mm, Lordotic
00889981064597Hollywood VI NM Sterile 11mm x 30mm x 9mm, Lordotic
00889981064580Hollywood VI NM Sterile 11mm x 30mm x 8mm, Lordotic
00889981034873Hollywood VI NM Sterile 11mm x 27mm x 18mm, Lordotic
00889981034866Hollywood VI NM Sterile 11mm x 27mm x 17mm, Lordotic
00889981034859Hollywood VI NM Sterile 11mm x 27mm x 16mm, Lordotic
00889981034842Hollywood VI NM Sterile 11mm x 27mm x 15mm, Lordotic
00889981034835Hollywood VI NM Sterile 11mm x 27mm x 14mm, Lordotic
00889981034828Hollywood VI NM Sterile 11mm x 27mm x 13mm, Lordotic
00889981034811Hollywood VI NM Sterile 11mm x 27mm x 12mm, Lordotic
00889981034804Hollywood VI NM Sterile 11mm x 27mm x 11mm, Lordotic
00889981034798Hollywood VI NM Sterile 11mm x 27mm x 10mm, Lordotic
00889981034781Hollywood VI NM Sterile 11mm x 27mm x 9mm, Lordotic
00889981034774Hollywood VI NM Sterile 11mm x 27mm x 8mm, Lordotic
00889981034767Hollywood VI NM Sterile 11mm x 27mm x 7mm, Lordotic

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.