FDA.reportPublic FDA data

STALIF C

Primary DI
00815101023700
Brand
STALIF C
Company
Centinel Spine, LLC
Model
C147561-3D-I
Published
2017-03-13
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
00815101023700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815101023700008151010237008151010237000815101023700

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
949024850
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843193111838Prodisc L InstrumentPDL1182026-06-08
00843193112323Prodisc C, SK, Vivo, Nova Instrument03.820.102.02S-CS2026-06-08
00843193112330Prodisc C, SK, Vivo, Nova Instrument03.820.103.02S-CS2026-06-08
00843193112347Prodisc C, SK, Vivo, Nova Instrument03.820.104.02S-CS2026-06-08
00843193112354Prodisc C, SK, Vivo, Nova Instrument03.820.105.02S-CS2026-06-08
00843193112361Prodisc C, SK, Vivo, Nova Instrument03.820.110.02S-CS2026-06-08
00843193119926Prodisc C, SK, Vivo, Nova Instrument03.820.102-CS2026-06-08
00843193119933Prodisc C, SK, Vivo, Nova Instrument03.820.103-CS2026-06-08
00843193119940Prodisc C, SK, Vivo, Nova Instrument03.820.104-CS2026-06-08
00843193119957Prodisc C, SK, Vivo, Nova Instrument03.820.105-CS2026-06-08
00843193119964Prodisc C, SK, Vivo, Nova Instrument03.820.106-CS2026-06-08
00843193119971Prodisc C, SK, Vivo, Nova Instrument03.820.107-CS2026-06-08
00843193119988Prodisc C, SK, Vivo, Nova Instrument03.820.108-CS2026-06-08
00843193119995Prodisc C, SK, Vivo, Nova Instrument03.820.109-CS2026-06-08
00843193120007Prodisc C, SK, Vivo, Nova Instrument03.820.110-CS2026-06-08
00843193111708Prodisc LPDL-L-PT10S2018-10-16
00843193111715Prodisc LPDL-L-PT12S2018-10-16
00843193111722Prodisc LPDL-L-PT14S2018-10-16
00843193111739Prodisc LPDL-L-SP06S2018-10-16
00843193111746Prodisc LPDL-L-SP11S2018-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017913664Saber-C Body (PT), 12x15x7 6 deg.ELEVATION SPINE, INC.OVE2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.ELEVATION SPINE, INC.OVE2026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.OVE2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.OVE2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.OVE2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.OVE2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.OVE2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.OVE2026-06-05
00810017913657Saber-C Body (PT), 12x15x6 6 deg.ELEVATION SPINE, INC.OVE2026-06-01
M711511410070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511410120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511411070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511411120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511412070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511412120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511606070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511607070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511607120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511608070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511608120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511609070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511609120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511610070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511610120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511611070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511611120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511612070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511612120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511806070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511807070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31