Super Staple™ Classic 22001

GUDID M963220010

Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains; 1ea Nitinol bone staple implant of dimensions 25 x 25 x 25mm with a 2.0mm x 3.0mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with a lock pin, 1ea 25mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 3.0mm Pull Pins, 1ea 3.0mm Drill Bit (color band of purple).

METRIC MEDICAL DEVICES, INC.

Orthopaedic bone staple, non-adjustable
Primary Device IDM963220010
NIH Device Record Keya303af59-90e1-4821-9f18-9d3690f79a8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuper Staple™ Classic
Version Model Number22001
Catalog Number22001
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
Phone830.535.6300
Emailsales@metricmd.com
Phone830.535.6300
Emailsales@metricmd.com
Phone830.535.6300
Emailsales@metricmd.com

Device Dimensions

Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter
Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter
Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter
Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter
Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter
Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter
Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter
Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter
Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter
Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter
Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter
Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter
Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter
Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter
Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter
Device Size Text, specify0
Depth25 Millimeter
Width25 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F
Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F
Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F
Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F
Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F
Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F
Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F
Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F
Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F
Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F
Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F
Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F
Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F
Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F
Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F
Special Storage Condition, SpecifyBetween 0 and 0 *Should not be subjected to storage or shipping tmeperatures in excess of 76.7°C or 170°F

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM963220010 [Primary]

FDA Product Code

JDRStaple, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-11-23
Device Publish Date2017-06-30

On-Brand Devices [Super Staple™ Classic]

M963224010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963220010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963219010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963218010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963217010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963214010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963213010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963175010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963173010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963172010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963171010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963170010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963169010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963168010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963166010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963174010Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
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