3D Printed Interbody Systems WL4-264500

GUDID 10889981306397

Lateral Implant, 23mm x 16mm x 45mm, 0 Deg, 3D

SEASPINE ORTHOPEDICS CORPORATION

Metallic spinal interbody fusion cage
Primary Device ID10889981306397
NIH Device Record Key12cf65c8-e0b7-4754-ba41-3a3ceee0d1bd
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D Printed Interbody Systems
Version Model NumberWL4-264500
Catalog NumberWL4-264500
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
GS110889981306397 [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 Date2024-04-15
Device Publish Date2024-04-06

On-Brand Devices [3D Printed Interbody Systems]

10889981282127Interbody, 18x15x12mm, 7 Degree, 3D
10889981282110Interbody, 18x15x12mm, 15 Degree, 3D
10889981282103Interbody, 18x15x12mm, 10 Degree, 3D
10889981282097Interbody, 18x15x11mm, 7 Degree, 3D
10889981282080Interbody, 18x15x11mm, 15 Degree, 3D
10889981282073Interbody, 18x15x11mm, 10 Degree, 3D
10889981282066Interbody, 18x15x10mm, 7 Degree, 3D
10889981282059Interbody, 18x15x10mm, 15 Degree, 3D
10889981282042Interbody, 18x15x10mm, 10 Degree, 3D
10889981282035Interbody, 18x15x9mm, 7 Degree, 3D
10889981282028Interbody, 18x15x9mm, 15 Degree, 3D
10889981282011Interbody, 18x15x9mm, 10 Degree, 3D
10889981282004Interbody, 18x15x8mm, 7 Degree, 3D
10889981281991Interbody, 18x15x8mm, 15 Degree, 3D
10889981281984Interbody, 18x15x8mm, 10 Degree, 3D
10889981281977Interbody, 18x15x7mm, 7 Degree, 3D
10889981281960Interbody, 18x15x7mm, 10 Degree, 3D
10889981281953Interbody, 18x15x6mm, 7 Degree, 3D
10889981281946Interbody, 18x15x6mm, 10 Degree, 3D
10889981281939Interbody, 18x15x5mm, 7 Degree, 3D
10889981281922Interbody, 16x14x12mm, 7 Degree, 3D
10889981281915Interbody, 16x14x12mm, 15 Degree, 3D
10889981281908Interbody, 16x14x12mm, 10 Degree, 3D
10889981281892Interbody, 16x14x11mm, 7 Degree, 3D
10889981281885Interbody, 16x14x11mm, 15 Degree, 3D
10889981281878Interbody, 16x14x11mm, 10 Degree, 3D
10889981281861Interbody, 16x14x10mm, 7 Degree, 3D
10889981281854Interbody, 16x14x10mm, 15 Degree, 3D
10889981281847Interbody, 16x14x10mm, 10 Degree, 3D
10889981281830Interbody, 16x14x9mm, 7 Degree, 3D
10889981281823Interbody, 16x14x9mm, 15 Degree, 3D
10889981281816Interbody, 16x14x9mm, 10 Degree, 3D
10889981281809Interbody, 16x14x8mm, 7 Degree, 3D
10889981281793Interbody, 16x14x8mm, 15 Degree, 3D
10889981281786Interbody, 16x14x8mm, 10 Degree, 3D
10889981281779Interbody, 16x14x7mm, 7 Degree, 3D
10889981281762Interbody, 16x14x7mm, 15 Degree, 3D
10889981281755Interbody, 16x14x7mm, 10 Degree, 3D
10889981281748Interbody, 16x14x6mm, 7 Degree, 3D
10889981281731Interbody, 16x14x6mm, 10 Degree, 3D
10889981281724Interbody, 16x14x5mm, 7 Degree, 3D
10889981281717Interbody, 16x12x12mm, 7 Degree, 3D
10889981281700Interbody, 16x12x5mm, 15 Degree, 3D
10889981281694Interbody, 16x12x12mm, 10 Degree, 3D
10889981281687Interbody, 16x12x11mm, 7 Degree, 3D
10889981281670Interbody, 16x12x5mm, 15 Degree, 3D
10889981281663Interbody, 16x12x11mm, 10 Degree, 3D
10889981281656Interbody, 16x12x10mm, 7 Degree, 3D
10889981281649Interbody, 16x12x5mm, 15 Degree, 3D
10889981281632Interbody, 16x12x10mm, 10 Degree, 3D

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.