STOMA® micro-screw

Basic Information

• Brand Name: STOMA® micro-screw
• Primary DI: ESAM23061131
• Version / Model: 23061.13
• Catalog Number: 23061.13
• Company Name: Storz am Mark GmbH
• Labeler DUNS: 318268125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2024-01-12
• Public Version: 1
• Public Version Date: 2024-01-22
• Public Version Status: New
• Public Device Record Key: b04960c9-eae4-4901-a5da-0ee6cf5abf20

Device Description

stoma® micro-screw, inner square, Ø 1,2mm, 13mm, 3 pcs are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures in the dental field. They are recommended especially for the fixation of transplanted bone blocks and small grafts during the augmentation process in the oral cavity and maxillomandibular surgical field, e.g. for horizontal, vertical or 3D augmentative grafts. The small-sized diameter of the screw head enables various applications. STOMA® micro-screws are delivered in non-sterile conditions.

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
DZL	Screw, Fixation, Intraosseous	Dental	872.4880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46638	Craniofacial bone screw, non-bioabsorbable	A small, threaded rod with a slotted head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	ESAM23061130	HIBCC
Primary	ESAM23061131	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K080430	000

Device Sizes

Type	Value	Unit	Text
Length	13	Millimeter
Outer Diameter	1.2	Millimeter