WaveForm TO WO4-128151

GUDID 10889981288686

Interbody, 11mm x 28mm x 15mm, 10 Deg, 3D

Seaspine Orthopedics Corporation

Metallic spinal interbody fusion cage
Primary Device ID10889981288686
NIH Device Record Keya1b2c341-294e-4cd3-aa05-f731faaa9c6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaveForm TO
Version Model NumberWO4-128151
Catalog NumberWO4-128151
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981288686 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHMIntervertebral fusion device with bone graft, thoracic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-29
Device Publish Date2025-12-19

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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