FDA.reportPublic FDA data

OIC Pedicle Screw System

Primary DI
M69622111200
Brand
OIC Pedicle Screw System
Company
ORTHOPAEDIC IMPLANT COMPANY, THE
Model
2211120
Device description
DISTRACTOR
Published
2017-02-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110046000ATHENA PEDICLE SCREW SYSTEMRoyal Oak Medical Devices2011-12-07NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M69622111200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. 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
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
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00840311244935Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244942Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
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00840311245024Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245062Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245079Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
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00840311245185Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
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00840311245239Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245253Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245284Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245345Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245369Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245970Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246007Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246014Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246045Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246113Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246175Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246250Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246267Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246298Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03