Reef TO TO1-128144

GUDID 10889981190187

Interbody, 11mm x 28mm x 14mm, 5 Deg

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis
Primary Device ID10889981190187
NIH Device Record Keyf5c7f1d1-9869-44ed-9051-616786e32cbb
Commercial Distribution StatusIn Commercial Distribution
Brand NameReef TO
Version Model NumberTO1-128144
Catalog NumberTO1-128144
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 Identifiers

Device Issuing AgencyDevice ID
GS110889981190187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-03
Device Publish Date2020-02-24

On-Brand Devices [Reef TO]

10889981213107T-Handle, Stainless Steel
10889981210786Caddy, 11mm x 28mm Trials
10889981210779Caddy, 9mm x 28mm Trials
10889981210755Caddy, 9mm x 24mm Trials
10889981210731TLIF-O Tray Level 2
10889981210724TLIF-O Tray Level 1
10889981210717TLIF-O Tray Case
10889981206369Trial, 9mm x 28mm x 7mm, 5 Deg
10889981206352Trial, 9mm x 24mm x 7mm, 5 Deg
10889981206345Trial, 11mm x 28mm x 7mm, 5 Deg
10889981206109Trial, 9mm x 28mm x 18mm, 15 Deg
10889981206093Trial, 9mm x 28mm x 18mm, 5 Deg
10889981206086Trial, 9mm x 28mm x 18mm, 10 Deg
10889981206062Trial, 9mm x 28mm x 17mm, 15 Deg
10889981206055Trial, 9mm x 28mm x 17mm, 5 Deg
10889981206048Trial, 9mm x 28mm x 17mm, 10 Deg
10889981206024Trial, 9mm x 28mm x 16mm, 15 Deg
10889981206017Trial, 9mm x 28mm x 16mm, 5 Deg
10889981206000Trial, 9mm x 28mm x 16mm, 10 Deg
10889981205980Trial, 9mm x 28mm x 15mm, 15 Deg
10889981205973Trial, 9mm x 28mm x 15mm, 5 Deg
10889981205966Trial, 9mm x 28mm x 15mm, 10 Deg
10889981205942Trial, 9mm x 28mm x 14mm, 15 Deg
10889981205935Trial, 9mm x 28mm x 14mm, 5 Deg
10889981205928Trial, 9mm x 28mm x 14mm, 10 Deg
10889981205904Trial, 9mm x 28mm x 13mm, 15 Deg
10889981205898Trial, 9mm x 28mm x 13mm, 5 Deg
10889981205881Trial, 9mm x 28mm x 13mm, 10 Deg
10889981205867Trial, 9mm x 28mm x 12mm, 15 Deg
10889981205850Trial, 9mm x 28mm x 12mm, 5 Deg
10889981205843Trial, 9mm x 28mm x 12mm, 10 Deg
10889981205829Trial, 9mm x 28mm x 11mm, 15 Deg
10889981205812Trial, 9mm x 28mm x 11mm, 5 Deg
10889981205805Trial, 9mm x 28mm x 11mm, 10 Deg
10889981205782Trial, 9mm x 28mm x 10mm, 15 Deg
10889981205775Trial, 9mm x 28mm x 10mm, 5 Deg
10889981205768Trial, 9mm x 28mm x 10mm, 10 Deg
10889981205744Trial, 9mm x 28mm x 9mm, 5 Deg
10889981205737Trial, 9mm x 28mm x 9mm, 10 Deg
10889981205713Trial, 9mm x 28mm x 8mm, 5 Deg
10889981205683Trial, 9mm x 24mm x 18mm, 15 Deg
10889981205676Trial, 9mm x 24mm x 18mm, 5 Deg
10889981205669Trial, 9mm x 24mm x 18mm, 10 Deg
10889981205645Trial, 9mm x 24mm x 17mm, 15 Deg
10889981205638Trial, 9mm x 24mm x 17mm, 5 Deg
10889981205621Trial, 9mm x 24mm x 17mm, 10 Deg
10889981205607Trial, 9mm x 24mm x 16mm, 15 Deg
10889981205591Trial, 9mm x 24mm x 16mm, 5 Deg
10889981205584Trial, 9mm x 24mm x 16mm, 10 Deg
10889981205560Trial, 9mm x 24mm x 15mm, 15 Deg

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