FDA.reportPublic FDA data

ODI 7.0mm Cannulated Screw System

Primary DI
B058CSS0011371
Brand
ODI 7.0mm Cannulated Screw System
Company
Orthopedic Designs North America, Inc.
Model
CSS001137
Device description
Washer
Published
2015-10-22
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
HTNWasher, Bolt Nut

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030619000ODI 7.0MM CANNULATED SCREW SYSTEMOrthopedic Designs, Inc.2003-04-01HTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B058CSS0011371PrimaryHIBCC0

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
Lumen/Inner Diameter7.2Millimeter
Outer Diameter13Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-635-8535support@odi-na.com

Regulatory Flags#

DUNS number
945518848
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
B058AHN08165L1Atlas™ Humeral Nail SystemAHN08165LAHN-08-165L2026-05-29
B058AHN08165R1Atlas™ Humeral Nail SystemAHN08165RAHN-08-165R2026-05-29
B058AHN5026NS1Atlas™ Humeral Nail SystemAHN5026NSAHN-5-026NS2026-05-04
B058AHN5028NS1Atlas™ Humeral Nail SystemAHN5028NSAHN-5-028NS2026-05-04
B058AHN5030NS1Atlas™ Humeral Nail SystemAHN5030NSAHN-5-030NS2026-05-04
B058AHN5032NS1Atlas™ Humeral Nail SystemAHN5032NSAHN-5-032NS2026-05-04
B058AHN11C00L1Atlas™ Humeral Nail SystemAHN11C00LAHN-11-C00-L2025-01-28
B058AHN11C05L1Atlas™ Humeral Nail SystemAHN11C05LAHN-11-C05-L2025-01-28
B058AHN11C10L1Atlas™ Humeral Nail SystemAHN11C10LAHN-11-C10-L2025-01-28
B058ART13C001ART End CapART13C00ART-13-C002021-11-29
B058ART13C051ART End CapART13C05ART-13-C052021-11-29
B058ART13C101ART End CapART13C10ART-13-C102021-11-29
B058ART13C151ART End CapART13C15ART-13-C152021-11-29
B058HTN10C011Talon™ DistalFix™ HTN End CapHTN10C01HTN-10-C012018-03-16
B058HTN10C01L1Talon™ DistalFix™ HTN End Cap LockingHTN10C01LHTN-10-C01-L2019-03-07
B058HTN10C051Talon™ DistalFix™ HTN End CapHTN10C05HTN-10-C052018-03-16
B058HTN10C05L1Talon™ DistalFix™ HTN End Cap LockingHTN10C05LHTN-10-C05-L2019-03-07
B058HTN10C101Talon™ DistalFix™ HTN End CapHTN10C10HTN-10-C102018-03-16
B058HTN10C10L1Talon™ DistalFix™ HTN End Cap LockingHTN10C10LHTN-10-C10-L2019-03-07
B058HTN10C151Talon™ DistalFix™ HTN End CapHTN10C15HTN-10-C152018-03-16

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Primary DI, Brand, Company table
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00850080543030PC Fix Extrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543047PC Fix Extrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543054PC Fix Intrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543061PC Fix Intrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543078PC Fix Thoracic Plate 70mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543085PC Fix Thoracic Plate 95mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
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