FDA.report

ROI-C

Primary DI
03662663047333
Brand
ROI-C
Company
LDR Spine Usa, Inc.
Model
SI-ROIC-0038
Catalog number
SI-ROIC-0038
Device description
ROI-C Final Impactor
Published
2017-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications

CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663047333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03662663047333036626630473333662663047333

GMDN Terms

TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
800-699-3360custserv@ldrspine.com

Regulatory Flags

DUNS number
615789729
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 DIBrandModelCatalogPublished
03662663059169Mobi-C Plug & Fit USMB9117R2024-01-15
03662663059176Mobi-C Plug & Fit USMB9174R2024-01-15
03662663059183Mobi-C Plug & Fit USMB9176R2024-01-15
03662663059145Mobi-C Plug & Fit USMB9100R2024-01-12
03662663059152Mobi-C Plug & Fit USMB9101R2024-01-12
03662663000215Mobi-CMB900RMB900R2018-12-12
03662663000222Mobi-CMB903RMB903R2018-12-13
03662663000239Mobi-CMB904RMB904R2018-12-12
03662663000246Mobi-CMB906RMB906R2018-12-12
03662663000369Mobi-CMB942RMB942R2018-12-12
03662663000376Mobi-CMB943RMB943R2018-12-13
03662663000383Mobi-CMB944RMB944R2018-12-13
03662663000390Mobi-CMB945RMB945R2018-12-13
03662663000406Mobi-CMB946RMB946R2018-12-13
03662663000413Mobi-CMB947RMB947R2018-12-13
03662663000420Mobi-CMB948RMB948R2018-12-13
03662663000437Mobi-CMB949RMB949R2018-12-13
03662663000819Mobi-C® Plug & Fit USMB9008R2014-09-24
03662663000826Mobi-C® Plug & Fit USMB9009R2014-09-24
03662663000833Mobi-C® Plug & Fit USMB9010R2014-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810056992743aprevoCarlsmed, Inc.OVE2026-03-17
00810056992804aprevoCarlsmed, Inc.OVE2026-03-17
00810056992866aprevoCarlsmed, Inc.OVE2026-03-17
00810056992958aprevoCarlsmed, Inc.OVE2026-03-17
00763000880422Endoskeleton™ TCS Interbody SystemMEDTRONIC SOFAMOR DANEK, INC.OVE2026-03-02
10195860030407E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030414E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030469E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030476E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030483E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030490E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030513E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030520E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030544E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030629E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030636E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030643E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030650E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030667E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030681E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030698E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030711E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030735E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030759E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030773E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030797E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030865E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030872E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030902E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030933E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20