FDA.report

3D Printed Interbody Systems

Primary DI
10889981304164
Brand
3D Printed Interbody Systems
Company
Seaspine Orthopedics Corporation
Model
WA4-241215
Catalog number
WA4-241215
Device description
2-Hole No-Profile Interbody, 43mm x 30mm x 12mm, 15 Deg, 3D
Published
2025-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions

SubmissionSupplement
K240830000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240830000Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody SystemOrthofix Medical, Inc.2024-06-20MAX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10889981304164PrimaryGS10

GMDN Terms

TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
079840876
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10889981135331Newport Complex MIS64-552564-55252026-03-03
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10889981135997Newport Complex MIS64-851064-85102026-03-03
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10889981136086Newport Complex MIS64-958564-95852026-03-03
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10889981145699NewPort™65-476065-47602026-03-03
10889981145750NewPort™65-555065-55502026-03-03
10889981145866NewPort™65-650065-65002026-03-03
10889981145903NewPort™65-653565-65352026-03-03

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Primary DIBrandCompanyProduct codePublished
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10889981304720MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981326241REEF LSeaspine Orthopedics CorporationOVD2026-03-03
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