Tatum Surgical Bone Fixation Screw Kit

Basic Information

• Brand Name: Tatum Surgical Bone Fixation Screw Kit
• Primary DI: 00083208000003
• Version / Model: E-Z bone Fixation Screw Kit
• Catalog Number: EZ-Bone Fixation Screw Kit
• Company Name: Suncoast Dental, Inc
• Labeler DUNS: 078352849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-13
• Public Version: 4
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 3cd90f1b-78f6-4cc7-a6b8-7356ba4cdfac

Device Description

Bone Fixation Self-Drilling Screw kit with various size of bone screw for securing bone blocks Tatum EZ-Fixation Bone Screw Kit. Includes: Cassette, Driver handle, Driver Tip, Latch grip driver tip, (5) 8mm, (5) 10mm, (5) 12mm, and (3) 14mm Screws, 1.0 and 1.8 Drill.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: Yes

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
61837	Craniofacial bone screw, non-bioabsorbable, non-sterile	A small, non-sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture treatment or for the fixation of transplanted bone chips and/or small grafts (e.g., during an intraoral bone augmentation procedure). The device 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 surgical steel, titanium (Ti)]. This device is intended to be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00083208000003	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141764	000