Intramedullary Fixation Scaffold (IFS) 2585S2

GUDID M9632585S20

'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 place with a locking pin; 1ea 1.1mm (0.045") Double trocar K-wire with sharps protection, and 1ea 2.7mm Drill Bit with 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 IDM9632585S20
NIH Device Record Key94a029ba-526e-4001-b437-20ef7acc8cdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntramedullary Fixation Scaffold (IFS)
Version Model Number2585S2
Catalog Number2585S2
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

Length23.7 Millimeter
Outer Diameter2.5 Millimeter
Length23.7 Millimeter
Outer Diameter2.5 Millimeter
Length23.7 Millimeter
Outer Diameter2.5 Millimeter
Length23.7 Millimeter
Outer Diameter2.5 Millimeter
Length23.7 Millimeter
Outer Diameter2.5 Millimeter
Length23.7 Millimeter
Outer Diameter2.5 Millimeter
Length23.7 Millimeter
Outer Diameter2.5 Millimeter
Length23.7 Millimeter
Outer Diameter2.5 Millimeter
Length23.7 Millimeter
Outer Diameter2.5 Millimeter
Length23.7 Millimeter
Outer Diameter2.5 Millimeter
Length23.7 Millimeter
Outer Diameter2.5 Millimeter
Length23.7 Millimeter
Outer Diameter2.5 Millimeter
Length23.7 Millimeter
Outer Diameter2.5 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
HIBCCM9632585S20 [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 Number3
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.