SuperScaffold™ 2265L3

GUDID M9632265L30

Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of findgers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol Intramedullary Fixation Scaffold (SuperScaffold™) implant held in place by use of a locking pin; 1ea 1.1mm (0.045") double trocar K-wire with sharps protection, and 1ea 2.2mm Drill Bit with integral handle for manual use.

METRIC MEDICAL DEVICES, INC.

Orthopaedic bone pin, non-bioabsorbable
Primary Device IDM9632265L30
NIH Device Record Keyc25b66a6-e743-41d7-a1d6-79fa80c1cc58
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuperScaffold™
Version Model Number2265L3
Catalog Number2265L3
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

Length6.5 Millimeter
Outer Diameter2.2 Millimeter
Length6.5 Millimeter
Outer Diameter2.2 Millimeter
Length6.5 Millimeter
Outer Diameter2.2 Millimeter
Length6.5 Millimeter
Outer Diameter2.2 Millimeter
Length6.5 Millimeter
Outer Diameter2.2 Millimeter
Length6.5 Millimeter
Outer Diameter2.2 Millimeter
Length6.5 Millimeter
Outer Diameter2.2 Millimeter
Length6.5 Millimeter
Outer Diameter2.2 Millimeter
Length6.5 Millimeter
Outer Diameter2.2 Millimeter
Length6.5 Millimeter
Outer Diameter2.2 Millimeter
Length6.5 Millimeter
Outer Diameter2.2 Millimeter
Length6.5 Millimeter
Outer Diameter2.2 Millimeter
Length6.5 Millimeter
Outer Diameter2.2 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
HIBCCM9632265L30 [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 Number2
Public Version Date2023-09-18
Device Publish Date2018-04-25

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