FDA.reportPublic FDA data

NovoHip Total Hip System

Primary DI
00811382038822
Brand
NovoHip Total Hip System
Company
Novosource, LLC
Model
1500-1049
Catalog number
1500-1049
Device description
NovoHip Modular Flex Shaft Driver
Published
2023-04-28
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
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LXHOrthopedic Manual Surgical Instrument
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140701000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140701000NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUGNovosource, Inc.2014-06-27OQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811382038822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811382038822008113820388228113820388220811382038822

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
17248588109info@novosource.com

Regulatory Flags#

DUNS number
081034828
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811382037658NovoHip Total Hip System1500-10161500-10162020-05-26
00811382037672NovoKnee Total Knee System3220-50243220-50242020-05-26
00811382037689NovoHip Total Hip System1345-36011345-36012020-11-03
00811382037696NovoHip Total Hip System1345-36021345-36022020-11-03
00811382037702NovoHip Total Hip System1345-36031345-36032020-11-03
00811382037719NovoHip Total Hip System1345-36041345-36042020-11-03
00811382037795NovoHip Total Hip System1345-28011345-28012021-04-20
00811382037801NovoHip Total Hip System1345-28021345-28022021-04-20
00811382037818NovoHip Total Hip System1345-28031345-28032021-04-20
00811382037825NovoHip Total Hip System1345-32011345-32012021-04-20
00811382037832NovoHip Total Hip System1345-32021345-32022021-04-20
00811382037849NovoHip Total Hip System1345-32031345-32032021-04-20
00811382037856NovoHip Total Hip System1345-32041345-32042021-04-20
00811382037726NovoKnee Total Knee System3120-51003120-51002024-07-19
00811382039287NovoHip Total Hip System1445-28051445-28052024-04-09
00811382039294NovoHip Total Hip System1445-32051445-32052024-04-09
00811382039300NovoHip Total Hip System1445-36051445-36052024-04-09
00811382039089NovoKnee Total Knee System3115-11013115-11012023-08-18
00811382039096NovoKnee Total Knee System3115-12013115-12012023-08-18
00811382039102NovoKnee Total Knee System3115-11023115-11022023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
M739153997700Cross Connector DriverCAPTIVA SPINE, INC.LXH2026-10-23
M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739243509000Implant Filling TubeCAPTIVA SPINE, INC.LXH2026-10-23
M739243511000Plunger RodCAPTIVA SPINE, INC.LXH2026-10-23
M739243512000Cannulated Drill, 7mmCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151066mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151077mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151088mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151099mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511010mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511111mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511212mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739983101200Coupling - Square ConnectCAPTIVA SPINE, INC.LXH2026-10-23
M739983240300Impaction T-HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739985202530Marking PinCAPTIVA SPINE, INC.LXH2026-10-23