FDA.report

Cortical Screw, 2.7mm

Primary DI
10812269022467
Brand
Cortical Screw, 2.7mm
Company
MIAMI DEVICE SOLUTIONS LLC
Model
MDS1002X32
Catalog number
MDS1002X32
Device description
Cortical Screw, Ø2.7 x L32mm
Published
2017-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10812269022467PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

Device Sizes

TypeValueUnit
Length32Millimeter
Outer Diameter2.7Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
(786) 422-1400customerservice@miamidevicesolutions.com

Regulatory Flags

DUNS number
078703080
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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10812269023730Extra Articular Distal Humerus PlateMDS170106RMDS170106R2018-01-02
10812269023747Extra Articular Distal Humerus PlateMDS170108RMDS170108R2018-01-02
10812269023754Extra Articular Distal Humerus PlateMDS170110RMDS170110R2018-01-02
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