The Titanium Fixation System
by Biomedics 510(k)
Active
510(k) K943071
Overview
The Titanium Fixation System is a bone plate device classified under the dental specialty. It is a substantially equivalent device cleared through the traditional 510(k) pathway.
The device received FDA 510(k) clearance under K943071 on January 6, 1995, and is manufactured by Biomedics. It is regulated under regulation number 872.4760 and assigned product code JEY.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK943071 | Date6 Jan 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JEY
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.4760
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Biomedics
Questions
What is the Titanium Fixation System used for?
The Titanium Fixation System is a bone plate device intended for use in dental specialty applications to stabilize bone fragments during healing, based on its classification and clearance as a substantially equivalent device under FDA 510(k) K943071.
How is the Titanium Fixation System supplied and is it sterile?
The device data does not specify sterility, single-use status, or packaging details; therefore, no information about how it is supplied or whether it is sterile can be derived from the provided authorization and specification fields.
What sizes or models are available for the Titanium Fixation System?
The device data does not include any details about sizes, models, dimensions, or reference numbers for the Titanium Fixation System beyond its name and K943071 clearance number, so specific sizing or model variations cannot be determined from this information.
What regulatory pathway was used for the Titanium Fixation System?
The Titanium Fixation System received FDA 510(k) clearance through the traditional pathway under K943071 on January 6, 1995, and was found substantially equivalent to a predicate device, as indicated by the decision code SESE and clearance_type 'Traditional'.