FDA.reportPublic FDA data

OIC Intramedullary Nail System

Primary DI
10811998036394
Brand
OIC Intramedullary Nail System
Company
ORTHOPAEDIC IMPLANT COMPANY, THE
Model
01-IM41
Device description
GUIDE PIN SLEEVE
Published
2018-07-31
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
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150655000OIC Intramedullary Nail SystemOrthopaedic Implant Company2015-07-09HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811998036394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081199803639410811998036394

GMDN Terms#

Term, Definition table
TermDefinition
Bone-nailing spacerA nonimplantable, surgical device intended to provide the correct spatial distance between an intramedullary bone nail and another device (e.g., aiming arm, implantable spacer) during bone nail implantation. It is typically a rod-like device made of high-grade stainless steel or synthetic materials. It is not a copy of a final implant (i.e., not a trial). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
775 636 8281Info@OrthoImplantCompany.com

Regulatory Flags#

DUNS number
070061160
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10811998032150OIC Cannulated Screw System01-SHS102018-07-31
10811998036301OIC Intramedullary Nail System01-IM302018-07-31
10811998036325OIC Intramedullary Nail System01-IM322018-07-31
10811998036349OIC Intramedullary Nail System01-IM342018-07-31
10811998036387OIC Intramedullary Nail System01-IM402018-07-31
10811998036561OIC Intramedullary Nail System01-IM582018-08-07
10811998038022OIC Intramedullary Nail System01-IMSE032018-08-07
10811998038039OIC Intramedullary Nail System01-IMSE042018-08-07
M69601IM300OIC Intramedullary Nail System01-IM302017-02-01
M69601IM320OIC Intramedullary Nail System01-IM322017-02-01
M69601IM340OIC Intramedullary Nail System01-IM342017-02-01
M69601IM400OIC Intramedullary Nail System01-IM402017-02-01
M69601IM410OIC Intramedullary Nail System01-IM412017-02-01
M69601SHS100OIC Cannulated Screw System01-SHS102017-02-01
10811998039555OIC Variable Angle Small Fragment Locking Plate System01-SF272023-09-06
10811998033478OIC Variable Angle Small Fragment Locking Plate System01-SF112018-07-31
10811998033485OIC Variable Angle Small Fragment Locking Plate System01-SF122018-07-31
M69601SF110OIC Variable Angle Small Fragment Locking Plate System01-SF112017-02-01
M69601SF120OIC Variable Angle Small Fragment Locking Plate System01-SF122017-02-01
10811998039845OIC Variable Angle Small Fragment Locking Plate SystemPHP-09172L2024-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M97012000112300DynaNailMedshape, Inc.HSB2026-10-16
08056693086397ELOS INSTRUMENTSINTRAUMA SPAHSB2026-10-13
08056693086403ELOS INSTRUMENTSINTRAUMA SPAHSB2026-10-13
08056693086410ELOS INSTRUMENTSINTRAUMA SPAHSB2026-10-13
00817867021044PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021051PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021068PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021075PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021082PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021099PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021105PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021112PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021129PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021136PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021143PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021150PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021167PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021174PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021181PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021198PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021204PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021211PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021228PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021235PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021242PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021259PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021266PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021273PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021280PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021297PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01