WaveForm TO WO1-128164

GUDID 10889981233112

Interbody, 11mm x 28mm x 16mm, 5 Deg, 3D

SEASPINE ORTHOPEDICS CORPORATION

Metallic spinal interbody fusion cage
Primary Device ID10889981233112
NIH Device Record Key32d3597f-c31c-456b-abcb-c63ea92c1773
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaveForm TO
Version Model NumberWO1-128164
Catalog NumberWO1-128164
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
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981233112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-12
Device Publish Date2021-05-04

On-Brand Devices [WaveForm TO]

10889981240066Interbody, 9mm x 28mm x 8mm, 10 Deg, 3D
10889981240059Interbody, 11mm x 32mm x 9mm, 10 Deg, 3D
10889981240042Interbody, 11mm x 28mm x 8mm, 10 Deg, 3D
10889981237974Interbody, 9mm x 28mm x 10mm, 15 Deg, 3D
10889981237967Interbody, 9mm x 28mm x 9mm, 10 Deg, 3D
10889981237950Interbody, 9mm x 24mm x 8mm, 10 Deg, 3D
10889981237943Interbody, 11mm x 28mm x 10mm, 15 Deg, 3D
10889981237936Interbody, 11mm x 28mm x 9mm, 10 Deg, 3D
10889981235338Interbody, 9mm x 28mm x 16mm, 15 Deg, 3D
10889981235321Interbody, 9mm x 28mm x 16mm, 5 Deg, 3D
10889981235307Interbody, 9mm x 28mm x 16mm, 10 Deg, 3D
10889981235291Interbody, 9mm x 28mm x 15mm, 15 Deg, 3D
10889981235284Interbody, 9mm x 28mm x 15mm, 5 Deg, 3D
10889981235260Interbody, 9mm x 28mm x 15mm, 10 Deg, 3D
10889981235253Interbody, 9mm x 28mm x 14mm, 15 Deg, 3D
10889981235246Interbody, 9mm x 28mm x 14mm, 5 Deg, 3D
10889981235222Interbody, 9mm x 28mm x 14mm, 10 Deg, 3D
10889981235215Interbody, 9mm x 28mm x 13mm, 15 Deg, 3D
10889981235208Interbody, 9mm x 28mm x 13mm, 5 Deg, 3D
10889981235185Interbody, 9mm x 28mm x 13mm, 10 Deg, 3D
10889981235178Interbody, 9mm x 28mm x 12mm, 15 Deg, 3D
10889981235161Interbody, 9mm x 28mm x 12mm, 5 Deg, 3D
10889981235147Interbody, 9mm x 28mm x 12mm, 10 Deg, 3D
10889981235130Interbody, 9mm x 28mm x 11mm, 15 Deg, 3D
10889981235123Interbody, 9mm x 28mm x 11mm, 5 Deg, 3D
10889981235109Interbody, 9mm x 28mm x 11mm, 10 Deg, 3D
10889981235093Interbody, 9mm x 28mm x 10mm, 5 Deg, 3D
10889981235079Interbody, 9mm x 28mm x 10mm, 10 Deg, 3D
10889981235062Interbody, 9mm x 28mm x 9mm, 5 Deg, 3D
10889981235048Interbody, 9mm x 28mm x 8mm, 5 Deg, 3D
10889981235024Interbody, 9mm x 28mm x 7mm, 5 Deg, 3D
10889981234904Interbody, 9mm x 24mm x 16mm, 10 Deg, 3D
10889981234867Interbody, 9mm x 24mm x 15mm, 10 Deg, 3D
10889981234829Interbody, 9mm x 24mm x 14mm, 10 Deg, 3D
10889981234782Interbody, 9mm x 24mm x 13mm, 10 Deg, 3D
10889981234744Interbody, 9mm x 24mm x 12mm, 10 Deg, 3D
10889981234706Interbody, 9mm x 24mm x 11mm, 10 Deg, 3D
10889981234669Interbody, 9mm x 24mm x 10mm, 10 Deg, 3D
10889981234638Interbody, 9mm x 24mm x 9mm, 10 Deg, 3D
10889981233501Interbody, 11mm x 32mm x 16mm, 10 Deg, 3D
10889981233464Interbody, 11mm x 32mm x 15mm, 10 Deg, 3D
10889981233426Interbody, 11mm x 32mm x 14mm, 10 Deg, 3D
10889981233389Interbody, 11mm x 32mm x 13mm, 10 Deg, 3D
10889981233341Interbody, 11mm x 32mm x 12mm, 10 Deg, 3D
10889981233303Interbody, 11mm x 32mm x 11mm, 10 Deg, 3D
10889981233273Interbody, 11mm x 32mm x 10mm, 10 Deg, 3D
10889981233129Interbody, 11mm x 28mm x 16mm, 15 Deg, 3D
10889981233112Interbody, 11mm x 28mm x 16mm, 5 Deg, 3D
10889981233099Interbody, 11mm x 28mm x 16mm, 10 Deg, 3D
10889981233082Interbody, 11mm x 28mm x 15mm, 15 Deg, 3D

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