Super Staple™ Classic 16901

GUDID M963169010

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 11x15x13mm with a 1.5mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 11mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 1.8mm Pull Pins; 1ea 1.8mm Drill Bit (color band of yellow)

METRIC MEDICAL DEVICES, INC.

Orthopaedic bone staple, non-adjustable

Primary Device ID	M963169010
NIH Device Record Key	b39ae5a9-bf7c-4e4b-9cd3-00e4a4b8ec84
Commercial Distribution Status	In Commercial Distribution
Brand Name	Super Staple™ Classic
Version Model Number	16901
Catalog Number	16901
Company DUNS	830255506
Company Name	METRIC MEDICAL DEVICES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	830-535-6300
Email	sales@metricmd.com
Phone	830-535-6300
Email	sales@metricmd.com
Phone	830-535-6300
Email	sales@metricmd.com
Phone	830-535-6300
Email	sales@metricmd.com
Phone	830-535-6300
Email	sales@metricmd.com
Phone	830-535-6300
Email	sales@metricmd.com
Phone	830-535-6300
Email	sales@metricmd.com
Phone	830-535-6300
Email	sales@metricmd.com
Phone	830-535-6300
Email	sales@metricmd.com
Phone	830-535-6300
Email	sales@metricmd.com
Phone	830-535-6300
Email	sales@metricmd.com
Phone	830-535-6300
Email	sales@metricmd.com
Phone	830-535-6300
Email	sales@metricmd.com
Phone	830-535-6300
Email	sales@metricmd.com
Phone	830-535-6300
Email	sales@metricmd.com
Phone	830-535-6300
Email	sales@metricmd.com

Device Dimensions

Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter
Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter
Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter
Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter
Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter
Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter
Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter
Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter
Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter
Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter
Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter
Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter
Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter
Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter
Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter
Device Size Text, specify	0
Width	11 Millimeter
Depth	15 Millimeter
Depth	13 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M963169010 [Primary]

FDA Product Code

JDR	Staple, Fixation, Bone

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2021-11-23
Device Publish Date	2016-09-26

On-Brand Devices [Super Staple™ Classic]

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M963219010	Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963218010	Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963217010	Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963214010	Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963213010	Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963175010	Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963173010	Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963172010	Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963171010	Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963170010	Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963169010	Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963168010	Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963166010	Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an
M963174010	Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation an