Osteotec SFI Sizer

Basic Information

• Brand Name: Osteotec SFI Sizer
• Primary DI: 05060183095809
• Version / Model: OSTF-Sizer
• Catalog Number: OSTF-Sizer
• Company Name: OSTEOTEC LIMITED
• Labeler DUNS: 348489386
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-26
• Public Version: 1
• Public Version Date: 2025-12-04
• Public Version Status: New
• Public Device Record Key: 5c3063df-7626-440c-a9f7-8cc4177dc65c

Device Description

The Osteotec SFI Sizer device comprises of eleven evenly scaled sizers, numbered from size 00 to size 9, to match the available sizes of the definitive implant, the Osteotec Silicone Finger Implant. These eleven sizes effectively constitute components of the Osteotec SFI Sizer, which is placed on the market as a single medical device. Each individual sizer is comprised of a blue flexible silicone elastomer. The sizers are used initially as a guide to choosing the correct size of implant and then, once that choice is made, to insert into the prepared joint space to enable the surgeon to check fit and function e.g. range of motion.

Device Characteristics

• Single Use: No
• 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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
HWT	Template	Orthopedic	888.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47807	Surgical implant/trial-implant/sizer holder, reusable	A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060183095809	GS1