FDA.reportPublic FDA data

Pisces-SC Standalone Cervical Interbody

Primary DI
B0623400161310
Brand
Pisces-SC Standalone Cervical Interbody
Company
Osseus Fusion Systems, LLC
Model
3400-1613-10LS
Catalog number
3400-1613-10LS
Device description
16x13x10, 6°, Standalone Cervical Interbody, Pisces-SC
Published
2026-10-28
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

Product Codes#

Code, Name table
CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261882000Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC2026-08-21OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0623400161310PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped 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 packaged with the cage.

Regulatory Flags#

DUNS number
933442068
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B0623400141205Pisces-SC Standalone Cervical Interbody3400-1412-05LS3400-1412-05LS2026-10-28
B0623400141206Pisces-SC Standalone Cervical Interbody3400-1412-06LS3400-1412-06LS2026-10-28
B0623400141207Pisces-SC Standalone Cervical Interbody3400-1412-07LS3400-1412-07LS2026-10-28
B0623400141208Pisces-SC Standalone Cervical Interbody3400-1412-08LS3400-1412-08LS2026-10-28
B0623400141209Pisces-SC Standalone Cervical Interbody3400-1412-09LS3400-1412-09LS2026-10-28
B0623400141210Pisces-SC Standalone Cervical Interbody3400-1412-10LS3400-1412-10LS2026-10-28
B0623400141211Pisces-SC Standalone Cervical Interbody3400-1412-11LS3400-1412-11LS2026-10-28
B0623400141212Pisces-SC Standalone Cervical Interbody3400-1412-12LS3400-1412-12LS2026-10-28
B0623400161305Pisces-SC Standalone Cervical Interbody3400-1613-05LS3400-1613-05LS2026-10-28
B0623400161306Pisces-SC Standalone Cervical Interbody3400-1613-06LS3400-1613-06LS2026-10-28
B0623400161307Pisces-SC Standalone Cervical Interbody3400-1613-07LS3400-1613-07LS2026-10-28
B0623400161308Pisces-SC Standalone Cervical Interbody3400-1613-08LS3400-1613-08LS2026-10-28
B0623400161309Pisces-SC Standalone Cervical Interbody3400-1613-09LS3400-1613-09LS2026-10-28
B0623400161311Pisces-SC Standalone Cervical Interbody3400-1613-11LS3400-1613-11LS2026-10-28
B0623400161312Pisces-SC Standalone Cervical Interbody3400-1613-12LS3400-1613-12LS2026-10-28
B0623400181405Pisces-SC Standalone Cervical Interbody3400-1814-05LS3400-1814-05LS2026-10-28
B0623400181406Pisces-SC Standalone Cervical Interbody3400-1814-06LS3400-1814-06LS2026-10-28
B0623400181407Pisces-SC Standalone Cervical Interbody3400-1814-07LS3400-1814-07LS2026-10-28
B0623400181408Pisces-SC Standalone Cervical Interbody3400-1814-08LS3400-1814-08LS2026-10-28
B0623400181409Pisces-SC Standalone Cervical Interbody3400-1814-09LS3400-1814-09LS2026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B0623400141205Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141206Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141207Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141208Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141209Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141210Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141211Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141212Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161305Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161306Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161307Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161308Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161309Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161311Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161312Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181405Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181406Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181407Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181408Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181409Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181410Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181411Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181412Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205010Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205012Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205014Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205016Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205018Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205020Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205110Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28