Intramedullary Fixation Scaffold (IFS) IFS2.5

GUDID M963IFS250

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; 3ea K-wires with sharps protection, and 1ea Drill Bit with integral handle for manual use.

METRIC MEDICAL DEVICES, INC.

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable
Primary Device IDM963IFS250
NIH Device Record Key57cafdec-fee6-4d04-a3f1-5f939ec21fd0
Commercial Distribution Discontinuation2018-07-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIntramedullary Fixation Scaffold (IFS)
Version Model NumberIFS2.5
Catalog NumberIFS2.5
Company DUNS830255506
Company NameMETRIC MEDICAL DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone830-535-6300
Emailsales@metricmd.com
Phone830-535-6300
Emailsales@metricmd.com
Phone830-535-6300
Emailsales@metricmd.com
Phone830-535-6300
Emailsales@metricmd.com
Phone830-535-6300
Emailsales@metricmd.com
Phone830-535-6300
Emailsales@metricmd.com
Phone830-535-6300
Emailsales@metricmd.com
Phone830-535-6300
Emailsales@metricmd.com
Phone830-535-6300
Emailsales@metricmd.com
Phone830-535-6300
Emailsales@metricmd.com
Phone830-535-6300
Emailsales@metricmd.com
Phone830-535-6300
Emailsales@metricmd.com
Phone830-535-6300
Emailsales@metricmd.com

Device Dimensions

Outer Diameter2.5 Millimeter
Length26.7 Millimeter
Outer Diameter2.5 Millimeter
Length26.7 Millimeter
Outer Diameter2.5 Millimeter
Length26.7 Millimeter
Outer Diameter2.5 Millimeter
Length26.7 Millimeter
Outer Diameter2.5 Millimeter
Length26.7 Millimeter
Outer Diameter2.5 Millimeter
Length26.7 Millimeter
Outer Diameter2.5 Millimeter
Length26.7 Millimeter
Outer Diameter2.5 Millimeter
Length26.7 Millimeter
Outer Diameter2.5 Millimeter
Length26.7 Millimeter
Outer Diameter2.5 Millimeter
Length26.7 Millimeter
Outer Diameter2.5 Millimeter
Length26.7 Millimeter
Outer Diameter2.5 Millimeter
Length26.7 Millimeter
Outer Diameter2.5 Millimeter
Length26.7 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM963IFS250 [Primary]

FDA Product Code

HTYPin, Fixation, Smooth

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-18
Device Publish Date2016-09-26

On-Brand Devices [Intramedullary Fixation Scaffold (IFS)]

M963IFS250Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such a
M9632585S30Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such a
M9632585S20'Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such
M9632585L30Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such a
M9632565S30Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such a
M9632565L30Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such a
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