FDA.reportPublic FDA data

OIC Cannulated Screw System

Primary DI
20811998035394
Brand
OIC Cannulated Screw System
Company
ORTHOPAEDIC IMPLANT COMPANY, THE
Model
07-036TP
Device description
WASHER 7MM - TITANIUM
Published
2018-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113123000OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEMThe Orthopaedic Implant Company2012-01-12KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811998035394PrimaryGS10
10811998035397Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081199803539420811998035394
1081199803539710811998035397

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washer, non-sterileA non-sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter7Millimeter

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
10
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078100004HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100011HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100028HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100035HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
20810152101418DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101425DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101432DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101449DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101456DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101463DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
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20810152101487DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101494DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
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20810152101555DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101562DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101579DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101586DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101593DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101609DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101616DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101623DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101630DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101647DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101654DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101661DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13