FDA.reportPublic FDA data

InstaFix Shape Memory Fixation System

Primary DI
B04140037030
Brand
InstaFix Shape Memory Fixation System
Company
OT MEDICAL, LLC
Model
400-3703
Catalog number
400-3703
Published
2015-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRStaple, Fixation, Bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B04140037030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustable, sterileA sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Millimeter
Width10Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(484) 588-2063wrhoda@otmedco.com

Regulatory Flags#

DUNS number
078738154
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B04140037010InstaFix Shape Memory Fixation System400-3701400-37012015-10-14
B04140037090InstaFix Shape Memory Fixation System400-3709400-37092015-10-14
B04140037150InstaFix Shape Memory Fixation System400-3715400-37152015-10-14
B04140037210InstaFix Shape Memory Fixation System400-3721400-37212015-10-14
B04140037220InstaFix Shape Memory Fixation System400-3722400-37222015-10-14
B04140037230InstaFix Shape Memory Fixation System400-3723400-37232015-10-14
B04140037240InstaFix Shape Memory Fixation System400-3724400-37242015-10-14
B04140037250InstaFix Shape Memory Fixation System400-3725400-37252015-10-14

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Primary DI, Brand, Company table
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10886705001033LUPINEDEPUY MITEK, LLCJDR2025-03-04
10886705001040LUPINEDEPUY MITEK, LLCJDR2025-03-04
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