FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
2.1 x 255mm Drill, 22mm Stop
K Number: K223199
·
Decision Nov 15, 2022
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
64
Applicant Total
25
Review Days
33
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- 2.1 x 255mm Drill, 22mm Stop
- K Number
- K223199
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Microfixation
- Date Received
- October 13, 2022
- Decision Date
- November 15, 2022
- Product Code
- HBE
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HBE), ordered by most recent decision date.
Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)
FDA 510(k)
FDA Class 2
·Neurology
Hubly Drill (H100)
FDA 510(k)
FDA Class 2
·Neurology
GREEN
FDA 510(k)
FDA Class 2
·Neurology
UniBur
FDA 510(k)
FDA Class 2
·Neurology
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)
FDA 510(k)
FDA Class 2
·Neurology
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Biomet Microfixation
| K Number | Device Name | ||
|---|---|---|---|
| K261002 | Pectus Blu System | Jun 2, 2026 | Substantially Equivalent |
| K241709 | Pectus Blu Support Bar System | Sep 19, 2024 | Substantially Equivalent |
| K212782 | SternaLock Sternal Closure System | May 17, 2022 | Substantially Equivalent |
| K212608 | RibFix Blu Thoracic Fixation System | Apr 22, 2022 | Substantially Equivalent |
| K213712 | Pectus Support Bar System | Mar 11, 2022 | Substantially Equivalent |
| K213208 | Twist Drills | Dec 23, 2021 | Substantially Equivalent |
| K202969 | Biomet Microfixation OmniMax MMF System | Aug 5, 2021 | Substantially Equivalent |
| K190576 | WalterLorenz Surgical Assist Arm Scope Holder | Jun 5, 2019 | Substantially Equivalent |
| K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Dec 9, 2016 | Substantially Equivalent |
| K163007 | Biomet Microfixation SternaLock 360 Sternal Closure System | Nov 23, 2016 | Substantially Equivalent |