FDA.reportPublic FDA data

Rhausler

Primary DI
08500591410629
Brand
Rhausler
Company
Rhausler Inc.
Model
C-7091
Catalog number
C-7091
Device description
PLAGE IMPLANT AND INSTRUMENT TRAY
Published
2024-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
K111272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111272000RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEMRhausler, Inc.2011-11-29OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08500591410629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08500591410629085005914106298500591410629

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 in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical 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 included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
015811277
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08500588270045RhauslerC-3127C-31272024-03-13
08500588270106RhauslerC-3240C-32402024-03-13
08500588270113RhauslerC-3243C-32432024-03-13
08500588270120RhauslerC-3246C-32462024-03-13
08500588270175RhauslerC-3357C-33572024-03-13
08500588270250RhauslerC-4121C-41212024-03-13
08500588270267RhauslerC-4123C-41232024-03-13
08500588270328RhauslerC-4135C-41352024-03-13
08500588270366RhauslerC-4246C-42462024-03-13
08500588270441RhauslerC-4366C-43662024-03-13
08500588270489RhauslerC-4378C-43782024-03-13
08500588270595RhauslerC-4509C-45092024-03-13
08500588270663RhauslerC-5133C-51332024-03-13
08500588270687RhauslerC-5237C-52372024-03-13
08500588270717RhauslerC-5246C-52462024-03-13
08500588270731RhauslerC-5252C-52522024-03-13
08500588270755RhauslerC-5354C-53542024-03-13
08500588270762RhauslerC-5357C-53572024-03-13
08500588270793RhauslerC-5366C-53662024-03-13
08500588270946RhauslerC-5509C-55092024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06009527234176SPICCA-SPSOUTHERN MEDICAL (PTY) LTDOVE2026-06-09
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