FDA.reportPublic FDA data

Intramedullary Fixation Scaffold (IFS)

Primary DI
M9632565L30
Brand
Intramedullary Fixation Scaffold (IFS)
Company
METRIC MEDICAL DEVICES, INC.
Model
2565L3
Catalog number
2565L3
Device description
"Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin, 1ea 1.1mm (0.045"") double trocar K-wire with sharps protection, and 1ea 2.7mm Drill Bit with integral handle for manual use."
Published
2016-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9632565L30PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length23.8Millimeter
Outer Diameter2.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
830-535-6300sales@metricmd.com

Regulatory Flags#

DUNS number
830255506
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9632265L30SuperScaffold™2265L32265L32018-04-25
M9632565S30Intramedullary Fixation Scaffold (IFS)2565S32565S32016-09-26
M9632585L30Intramedullary Fixation Scaffold (IFS)2585L32585L32016-12-13
M9632585S20Intramedullary Fixation Scaffold (IFS)2585S22585S22016-09-26
M9632585S30Intramedullary Fixation Scaffold (IFS)2585S32585S32016-12-13
M963IFS250Intramedullary Fixation Scaffold (IFS)IFS2.5IFS2.52016-09-26
M96316TT0LINK™ External Fixator16TT16TT2024-06-07
M96320TG0LINK™ External Fixator20TG20TG2024-06-07
M96320TT0LINK™ External Fixator20TT20TT2024-06-07
M96322000200LINK™ External Fixator2-2000202-2000202024-06-07
M9634H201020LINK™ External Fixator4H2010204H2010202024-06-07
M963C200LINK™ External FixatorC-20C-202024-06-07
M963CH20100LINK™ External FixatorCH2010CH20102024-06-07
M963174010Super Staple™ Classic17401174012016-09-26
M963200630SuperSTEP™20063200632018-09-07
M963200830SuperSTEP™20083200832018-09-07
M963201030SuperSTEP™20103201032018-09-07
M963166010Super Staple™ Classic16601166012017-10-31
M963168010Super Staple™ Classic16801168012016-09-26
M963169010Super Staple™ Classic16901169012016-09-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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