FDA.report

ROI-T

Primary DI
03662663040211
Brand
ROI-T
Company
LDR Spine Usa, Inc.
Model
IR9009R
Catalog number
IR9009R
Published
2019-01-03
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663040211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03662663040211036626630402113662663040211

GMDN Terms

TermDefinition
Orthopaedic graft inserterA hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a variety of designs, such as a plunger made of high-grade materials [e.g., stainless steel or titanium (Ti)] used to advance the graft down its tubular-shaped holder or possibly a bone graft funnel and into place; it is also available in a variety of sizes. This is a reusable device.

Device Sizes

TypeValueUnit
Height8Millimeter

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
true
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

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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
00840283403187LumiVy™VY SPINE LLCMAX2026-03-24
00840283403194LumiVy™VY SPINE LLCMAX2026-03-24
00840283403200LumiVy™VY SPINE LLCMAX2026-03-24
00840283403217LumiVy™VY SPINE LLCMAX2026-03-24
00840283403224LumiVy™VY SPINE LLCMAX2026-03-24
06009527200096TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200102TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200119TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200126TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200133TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200140TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200157TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200164TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200218TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200225TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200232TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200249TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200256TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200263TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
03662663130929Zyston Interbody Spacer SystemHighridge Medical, LLCMAX2026-03-17
03662663130936Zyston Interbody Spacer SystemHighridge Medical, LLCMAX2026-03-17
03662663131117Zyston Interbody Spacer SystemHighridge Medical, LLCMAX2026-03-17
04052536018192pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018208pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018215pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018222pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018239pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018246pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018253pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018260pezoUlrich GmbH & Co. KGMAX2026-03-16