FDA.reportPublic FDA data

ROI-C

Primary DI
03662663002950
Brand
ROI-C
Company
LDR Spine Usa, Inc.
Model
MC9096R-S
Catalog number
MC9096R-S
Device description
STERILE LONG STARTER AWL FOR ROI-C ANCHORING PLATE
Published
2017-03-24
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

Contact Domains#

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
K151934000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151934000ROI-C Titanium-Coated Implant SystemLdr Spine USA2015-12-07OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662663002950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663002950036626630029503662663002950

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
615789729
Device count
1
Lot or batch
true
Expiration date on label
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
03662663043083ROI-AIR9432RIR9432R2018-12-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776391720CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391737CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391744CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391751CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391768CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391775CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391782CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391799CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391805CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391812CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391829CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391836CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391843CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391850CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391867CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391874CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391881CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391898CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391904CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391911CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391928CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391935CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391942CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391959CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391966CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391973CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391980CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391997CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776392000CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776392017CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11