Zuma-L™ 56-4112

GUDID 10889981059255

Zuma-L Implant 40mm x 18mm x 12mm, 0 Deg

SEASPINE ORTHOPEDICS CORPORATION

Spinal fixation plate, non-bioabsorbable
Primary Device ID10889981059255
NIH Device Record Keyc17f4eea-46e8-4fb1-afa7-be7327fac992
Commercial Distribution Discontinuation2016-09-02
Commercial Distribution StatusNot in Commercial Distribution
Brand NameZuma-L™
Version Model Number56-4112
Catalog Number56-4112
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
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 Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981059255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981059255]

Moist Heat or Steam Sterilization

[10889981059255]

Moist Heat or Steam Sterilization

[10889981059255]

Moist Heat or Steam Sterilization

[10889981059255]

Moist Heat or Steam Sterilization

[10889981059255]

Moist Heat or Steam Sterilization

[10889981059255]

Moist Heat or Steam Sterilization

[10889981059255]

Moist Heat or Steam Sterilization

[10889981059255]

Moist Heat or Steam Sterilization

[10889981059255]

Moist Heat or Steam Sterilization

[10889981059255]

Moist Heat or Steam Sterilization

[10889981059255]

Moist Heat or Steam Sterilization

[10889981059255]

Moist Heat or Steam Sterilization

[10889981059255]

Moist Heat or Steam Sterilization

[10889981059255]

Moist Heat or Steam Sterilization

[10889981059255]

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 [Zuma-L™]

10889981062521Zuma-L 3 Implant
10889981062514Zuma-L 2 Implant
10889981060152Height Trial, 45mm x 18mm, 8° , L4-L5
10889981060145Height Trial, 45mm x 16mm, 8° , L4-L5
10889981060138Height Trial, 45mm x 14mm, 8° , L4-L5
10889981060121Height Trial, 45mm x 12mm, 8° , L4-L5
10889981060114Height Trial, 45mm x 10mm, 8° , L4-L5
10889981060107Height Trial, 45mm x 8mm, 8° , L4-L5
10889981060091Angled Starter Trial
10889981060084Zuma-L Depth Trial, L4-L5
10889981060077Height Trial, 45mm x 18mm, 0 ° , L4-L5
10889981060060Height Trial, 45mm x 16mm, 0 ° , L4-L5
10889981060053Height Trial, 45mm x 14mm, 0 ° , L4-L5
10889981060046Height Trial, 45mm x 12mm, 0 ° , L4-L5
10889981060039Height Trial, 45mm x 10mm, 0 ° , L4-L5
10889981060022Height Trial, 45mm x 8mm, 0 ° , L4-L5
10889981060015Height Trial, 45mm x 18mm, 0 Deg
10889981060008Height Trial, 45mm x 16mm, 0 Deg
10889981059996Height Trial, 45mm x 14mm, 0 Deg
10889981059989Height Trial, 45mm x 12mm, 0 Deg
10889981059972Height Trial, 45mm x 10mm, 0 Deg
10889981059965Height Trial, 45mm x 08mm, 0 Deg
10889981059958Height Trial, 45 mm x 18 mm, 8°
10889981059941Height Trial, 45 mm x 16 mm, 8°
10889981059934Height Trial, 45 mm x 14 mm, 8°
10889981059927Height Trial, 45 mm x 12 mm, 8°
10889981059910Height Trial, 45 mm x 10 mm, 8°
10889981059903Height Trial, 45 mm x 08 mm, 8°
10889981059897Lateral Depth Trial, Small Hudson
10889981059880Zuma-L Locking Cover, 18mm
10889981059873Zuma-L Locking Cover, 16mm
10889981059866Zuma-L Locking Cover, 14mm
10889981059859Zuma-L Locking Cover, 12mm
10889981059842Zuma-L Locking Cover, 10mm
10889981059835Zuma-L Locking Cover, 8mm
10889981059828Bone Screw, 6.5 x 65mm
10889981059811Bone Screw, 6.5 x 60mm
10889981059804Bone Screw, 6.5 x 55mm
10889981059798Bone Screw, 6.5 x 50mm
10889981059781Bone Screw, 6.5 x 45mm
10889981059774Bone Screw, 6.5 x 40mm
10889981059767Bone Screw, 6.5 x 35mm
10889981059750Bone Screw, 6.5 x 30mm
10889981059743Bone Screw, 6.5 x 25mm
10889981059736Bone Screw, 5.5 x 65mm
10889981059729Bone Screw, 5.5 x 60mm
10889981059712Bone Screw, 5.5 x 55mm
10889981059705Bone Screw, 5.5 x 50mm
10889981059699Bone Screw, 5.5 x 45mm
10889981059682Bone Screw, 5.5 x 40mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.