FDA.reportPublic FDA data

STALIF C

Primary DI
00840402505648
Brand
STALIF C
Company
Silony Medical GmbH
Model
C165539-3T
Catalog number
C165539-3T
Device description
STALIF C 3 Hole Tapered Cage 16 X 5.5
Published
2025-11-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K120819000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120819000STALIF CCentinel Spine, Inc.2012-08-31OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815101023830PreviousGS10
00840402505648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815101023830008151010238308151010238300815101023830
00840402505648008404025056488404025056480840402505648

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric 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 non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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 table
Method

Regulatory Flags#

DUNS number
312969760
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04054896000770AwlVI-1010VI-10102026-09-18
04054896000787AwlVI-1020VI-10202026-09-18
04054896000831Control GaugesVI-1040VI-10402026-09-18
04054896000855Implant ModifierVI-1160VI-11602026-09-18
04054896000862Implant ModifierVI-1250VI-12502026-09-18
04054896000879Implant ModifierVI-1270VI-12702026-09-18
04054896000886Forceps and ClampsVI-1320VI-13202026-09-18
04054896000893(Re-) Positioning ToolsVI-1340VI-13402026-09-18
04054896000909(Re-) Positioning ToolsVI-1360VI-13602026-09-18
04054896000916(Re-) Positioning ToolsVI-1361VI-13612026-09-18
04054896000923AdapterVI-1362VI-13622026-09-18
04054896000930(Re-) Positioning ToolsVI-1363VI-13632026-09-18
04054896000947AdapterVI-1410VI-14102026-09-18
04054896000985Torque LimiterVI-1450VI-14502026-09-18
04054896000992(Re-) Positioning ToolsVI-1510VI-15102026-09-18
04054896001005Forceps and ClampsVI-1530VI-15302026-09-18
04054896001012Implant ModifierVI-1610VI-16102026-09-18
04054896001029Forceps and ClampsVI-1620VI-16202026-09-18
04054896001036Forceps and ClampsVI-1630VI-16302026-09-18
04054896001067Forceps and ClampsVI-1820VI-18202026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810216329235ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329242ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329259ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329266ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329273ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329280ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329297ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329303ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329310ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329334ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329341ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329358ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329372ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329389ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329396ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329402ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329419ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00889981124390Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124406Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124413Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124420Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124437Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124444Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124451Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124468Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142301Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142318Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142325Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142332Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142349Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26