SOLUSTAPLE 114023ND

GUDID M248114023ND1

The SOLUSTAPLE is a staple with two self-drilling tips. The treatment with a SOLUSTAPLE allow, after possible treatment of the second ray, to recreate a square or Greek foot. Two types of staples are available (90 or 116 degrees interaxis). In order to safeguard the function of the joint, the staple with oblique design will be used. It is made out of stainless steel, and it is delivered non sterile.

NEWDEAL

Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

Primary Device ID	M248114023ND1
NIH Device Record Key	f545b3c2-1417-47d0-9ee2-d0d163a0defc
Commercial Distribution Status	In Commercial Distribution
Brand Name	SOLUSTAPLE
Version Model Number	114023ND
Catalog Number	114023ND
Company DUNS	536935331
Company Name	NEWDEAL
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com

Device Dimensions

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Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780052401 [Primary]
HIBCC	M248114023ND1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K991566

FDA Product Code

JDR	STAPLE, FIXATION, BONE