SeaSpine Spacer System - Redondo™ 93-6110

GUDID 10889981045067

Redondo Inserter

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implant inserter/extractor, reusable
Primary Device ID10889981045067
NIH Device Record Key4dfe408e-8f5d-4f92-9a50-303986804f0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeaSpine Spacer System - Redondo™
Version Model Number93-6110
Catalog Number93-6110
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(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981045067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981045067]

Moist Heat or Steam Sterilization

[10889981045067]

Moist Heat or Steam Sterilization

[10889981045067]

Moist Heat or Steam Sterilization

[10889981045067]

Moist Heat or Steam Sterilization

[10889981045067]

Moist Heat or Steam Sterilization

[10889981045067]

Moist Heat or Steam Sterilization

[10889981045067]

Moist Heat or Steam Sterilization

[10889981045067]

Moist Heat or Steam Sterilization

[10889981045067]

Moist Heat or Steam Sterilization

[10889981045067]

Moist Heat or Steam Sterilization

[10889981045067]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2015-09-24

On-Brand Devices [SeaSpine Spacer System - Redondo™]

10889981045869Redondo Trial 26mm x 24mm x 22mm, 8 Deg
10889981045852Redondo Trial 26mm x 24mm x 20mm, 8 Deg
10889981045845Redondo Trial 26mm x 24mm x 18mm, 8 Deg
10889981045838Redondo Trial 26mm x 24mm x 16mm, 8 Deg
10889981045821Redondo Trial 26mm x 24mm x 14mm, 8 Deg
10889981045814Redondo Trial 26mm x 24mm x 12mm, 8 Deg
10889981045807Redondo Trial 26mm x 24mm x 10mm, 8 Deg
10889981045791Redondo Trial 38mm x 26mm x 22mm, 12 Deg
10889981045784Redondo Trial 38mm x 26mm x 20mm, 12 Deg
10889981045777Redondo Trial 38mm x 26mm x 18mm, 12 Deg
10889981045760Redondo Trial 38mm x 26mm x 16mm, 12 Deg
10889981045753Redondo Trial 38mm x 26mm x 14mm, 12 Deg
10889981045746Redondo Trial 38mm x 26mm x 12mm, 12 Deg
10889981045739Redondo Trial 38mm x 26mm x 10mm, 12 Deg
10889981045722Redondo Trial 38mm x 26mm x 22mm, 8 Deg
10889981045715Redondo Trial 38mm x 26mm x 20mm, 8 Deg
10889981045708Redondo Trial 38mm x 26mm x 18mm, 8 Deg
10889981045692Redondo Trial 38mm x 26mm x 16mm, 8 Deg
10889981045685Redondo Trial 38mm x 26mm x 14mm, 8 Deg
10889981045678Redondo Trial 38mm x 26mm x 12mm, 8 Deg
10889981045661Redondo Trial 38mm x 26mm x 10mm, 8 Deg
10889981045654Redondo Trial 30mm x 24mm x 22mm, 5 Deg
10889981045647Redondo Trial 30mm x 24mm x 20mm, 5 Deg
10889981045630Redondo Trial 30mm x 24mm x 18mm, 5 Deg
10889981045623Redondo Trial 30mm x 24mm x 16mm, 5 Deg
10889981045616Redondo Trial 30mm x 24mm x 14mm, 5 Deg
10889981045609Redondo Trial 30mm x 24mm x 12mm, 5 Deg
10889981045593Redondo Trial 30mm x 24mm x 10mm, 5 Deg
10889981045586Redondo Trial 34mm x 24mm x 22mm, 12 Deg
10889981045579Redondo Trial 34mm x 24mm x 20mm, 12 Deg
10889981045562Redondo Trial 34mm x 24mm x 18mm, 12 Deg
10889981045555Redondo Trial 34mm x 24mm x 16mm, 12 Deg
10889981045548Redondo Trial 34mm x 24mm x 14mm, 12 Deg
10889981045531Redondo Trial 34mm x 24mm x 12mm, 12 Deg
10889981045524Redondo Trial 34mm x 24mm x 10mm, 12 Deg
10889981045517Redondo Trial 34mm x 24mm x 22mm, 8 Deg
10889981045500Redondo Trial 34mm x 24mm x 20mm, 8 Deg
10889981045494Redondo Trial 34mm x 24mm x 18mm, 8 Deg
10889981045487Redondo Trial 34mm x 24mm x 16mm, 8 Deg
10889981045470Redondo Trial 34mm x 24mm x 14mm, 8 Deg
10889981045463Redondo Trial 34mm x 24mm x 12mm, 8 Deg
10889981045456Redondo Trial 34mm x 24mm x 10mm, 8 Deg
10889981045449Trial, 30mm x 24mm x 22mm, 15 Deg Lordotic
10889981045432Trial, 30mm x 24mm x 20mm, 15 Deg Lordotic
10889981045425Trial, 30mm x 24mm x 18mm, 15 Deg Lordotic
10889981045418Trial, 30mm x 24mm x 16mm, 15 Deg Lordotic
10889981045401Trial, 30mm x 24mm x 14mm, 15 Deg Lordotic
10889981045395Trial, 30mm x 24mm x 12mm, 15 Deg Lordotic
10889981045388Trial, 30mm x 24mm x 22mm, 10 Deg Lordotic
10889981045371Trial, 30mm x 24mm x 20mm, 10 Deg Lordotic
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.