WaveForm TO WO4-928145

GUDID 10889981286705

Interbody, 9mm x 28mm x 14mm, 15 Deg, 3D

Seaspine Orthopedics Corporation

Metallic spinal interbody fusion cage
Primary Device ID10889981286705
NIH Device Record Keyc21d337b-c034-4902-9c35-7f64226c5b8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaveForm TO
Version Model NumberWO4-928145
Catalog NumberWO4-928145
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
GS110889981286705 [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 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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.