SOLUSTAPLE

Basic Information

• Brand Name: SOLUSTAPLE
• Primary DI: 10381780052401
• Version / Model: 114023ND
• Catalog Number: 114023ND
• Company Name: NEWDEAL
• Labeler DUNS: 536935331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-09
• Public Version: 6
• Public Version Date: 2023-02-09
• Public Version Status: Update
• Public Device Record Key: f545b3c2-1417-47d0-9ee2-d0d163a0defc
• Distribution End Date: 2027-12-31

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JDR	STAPLE, FIXATION, BONE	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61669	Orthopaedic bone staple, non-adjustable	A non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M248114023ND1	HIBCC
Primary	10381780052401	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K991566	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			116 degrees interaxis x 8mm length x 9.5mm width

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dry place.