FDA.reportPublic FDA data

ROI-A

Primary DI
03662663043083
Brand
ROI-A
Company
LDR Spine Usa, Inc.
Model
IR9432R
Catalog number
IR9432R
Published
2018-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153495000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153495000Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant SystemLdr Spine USA2016-03-31MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662663043083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663043083036626630430833662663043083

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-699-3360custserv@ldrspine.com

Regulatory Flags#

DUNS number
615789729
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662663000369Mobi-CMB942RMB942R2018-12-12
03662663002899Avenue TAT9033RAT9033R2017-04-12
03662663002912Avenue TAT9035RAT9035R2017-04-12
03662663033039VFTVF9004RVF9004R2017-05-19
03662663033169VFTVF9105RVF9105R2017-05-19
03662663036863EasyspineES9038RES9038R2018-12-11
03662663037402InterBRIDGEIB9003RIB9003R2018-12-12
03662663041447ROI-TIR9098RIR9098R2018-12-12
03662663041676ROI-AIR9202RIR9202R2017-03-23
03662663043076ROI-AIR9431RIR9431R2018-12-12
03662663043175ROI-CMC9002RMC9002R2017-03-23
03662663043182ROI-CMC9003RMC9003R2017-03-23
03662663043632MC+MC908RMC908R2018-12-11
03662663043656ROI-CMC9092RMC9092R2017-03-23
03662663043663ROI-CMC9093RMC9093R2017-03-23
03662663043670ROI-CMC9094RMC9094R2017-03-23
03662663044165MC+MC937RMC937R2018-12-11
03662663044172MC+MC938RMC938R2018-12-11
03662663044332MC+MC960RMC960R2018-12-11
03662663045506MC+MC928RMC928R2018-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B707125355730300DUALX DUAL PORTAL DISPOSABLE KIT-30MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730400DUALX DUAL PORTAL DISPOSABLE KIT-40MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730500DUALX DUAL PORTAL DISPOSABLE KIT-50MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730600DUALX DUAL PORTAL DISPOSABLE KIT-60MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730700DUALX DUAL PORTAL DISPOSABLE KIT-70MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730800DUALX DUAL PORTAL DISPOSABLE KIT-80MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730900DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731000DUALX DUAL PORTAL DISPOSABLE KIT-100MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731100DUALX DUAL PORTAL DISPOSABLE KIT-110MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731200DUALX DUAL PORTAL DISPOSABLE KIT-120MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
00763000703929MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000703936MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000703950MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000703967MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000703981MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000703998MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704001MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704018MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704025MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704032MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704049MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704063MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704070MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704100MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704117MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704124MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704131MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704148MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704155MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704162MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27