FDA.reportPublic FDA data

OIC Intramedullary Nail System

Primary DI
10811998036301
Brand
OIC Intramedullary Nail System
Company
ORTHOPAEDIC IMPLANT COMPANY, THE
Model
01-IM30
Device description
IMPACTOR IM NAIL
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
10811998036301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081199803630110811998036301

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). 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
10811998036325OIC Intramedullary Nail System01-IM322018-07-31
10811998036349OIC Intramedullary Nail System01-IM342018-07-31
10811998036387OIC Intramedullary Nail System01-IM402018-07-31
10811998036394OIC Intramedullary Nail System01-IM412018-07-31
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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