Wire, Fixation, Intraosseous
The Intraosseous Fixation Wire is a dental and oral surgical device, implanted within bone, used to stabilize fractures of the jaw or facial skeleton or to secure bone grafts during surgical repair and healing. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DZK and the applicable regulation is 21 CFR 872.4880, under the Dental medical specialty. This device is an implant.
Research product code DZK in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- DZK
- Device Class
- FDA class 2
- Regulation Number
- 872.4880
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K092530 | SPRYTIE, MODELS ST001, ST002 AND ST003 | Apr 02, 2010 | Substantially Equivalent | Russell B. Walther |
| K022821 | ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E | Nov 15, 2002 | Substantially Equivalent | Ideatrics, Inc. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.