3D Printed Interbody Systems AC4-227085

GUDID 10889981281298

Interbody, 20x17x8mm, 15 Degree, 3D

SEASPINE ORTHOPEDICS CORPORATION

Metallic spinal interbody fusion cage
Primary Device ID10889981281298
NIH Device Record Keya722858a-f27a-497b-a3c2-46182d8d6c7c
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D Printed Interbody Systems
Version Model NumberAC4-227085
Catalog NumberAC4-227085
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981281298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-22
Device Publish Date2022-08-12

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

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