FDA.reportPublic FDA data

Pisces-SC Standalone Cervical Interbody

Primary DI
B06234500053
Brand
Pisces-SC Standalone Cervical Interbody
Company
Osseus Fusion Systems, LLC
Model
3450-0053
Catalog number
3450-0053
Device description
09-10 DTS Guide Head, Pisces-SC
Published
2026-10-29
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
false

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
B06234500053PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

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
B06234500010Pisces-SC Standalone Cervical Interbody3450-00103450-00102026-10-29
B06234500020Pisces-SC Standalone Cervical Interbody3450-00203450-00202026-10-29
B06234500030Pisces-SC Standalone Cervical Interbody3450-00303450-00302026-10-29
B06234500040Pisces-SC Standalone Cervical Interbody3450-00403450-00402026-10-29
B06234500050Pisces-SC Standalone Cervical Interbody3450-00503450-00502026-10-29
B06234500052Pisces-SC Standalone Cervical Interbody3450-00523450-00522026-10-29
B06234500054Pisces-SC Standalone Cervical Interbody3450-00543450-00542026-10-29
B06234500061Pisces-SC Standalone Cervical Interbody3450-00613450-00612026-10-29
B06234500062Pisces-SC Standalone Cervical Interbody3450-00623450-00622026-10-29
B06234500063Pisces-SC Standalone Cervical Interbody3450-00633450-00632026-10-29
B06234500064Pisces-SC Standalone Cervical Interbody3450-00643450-00642026-10-29
B06234500070Pisces-SC Standalone Cervical Interbody3450-00703450-00702026-10-29
B06234500071Pisces-SC Standalone Cervical Interbody3450-00713450-00712026-10-29
B06234500080Pisces-SC Standalone Cervical Interbody3450-00803450-00802026-10-29
B06234500081Pisces-SC Standalone Cervical Interbody3450-00813450-00812026-10-29
B06234500090Pisces-SC Standalone Cervical Interbody3450-00903450-00902026-10-29
B06234500100Pisces-SC Standalone Cervical Interbody3450-01003450-01002026-10-29
B06234500110Pisces-SC Standalone Cervical Interbody3450-01103450-01102026-10-29
B06234500121Pisces-SC Standalone Cervical Interbody3450-01213450-01212026-10-29
B06234500122Pisces-SC Standalone Cervical Interbody3450-01223450-01222026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B06234500010Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500020Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500030Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500040Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500050Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500052Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500054Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500061Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500062Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500063Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500064Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500070Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500071Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500080Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500081Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500090Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500100Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500110Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500121Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500122Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500123Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500130Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500140Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500150Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500160Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500170Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500180Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B062345014120506Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B062345014120708Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B062345014120910Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29