FDA.reportPublic FDA data

Pisces-SC Standalone Cervical Interbody

Primary DI
B06234205018
Brand
Pisces-SC Standalone Cervical Interbody
Company
Osseus Fusion Systems, LLC
Model
3420-5018
Catalog number
3420-5018
Device description
Bone Screw, Ø3.5x18mm, Self-Drilling, 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
false
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
B06234205018PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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
B0623400161310Pisces-SC Standalone Cervical Interbody3400-1613-10LS3400-1613-10LS2026-10-28
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

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
B0623400161310Pisces-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
B06234205020Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205110Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28