FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Twist Drills
K Number: K213208
·
Decision Dec 23, 2021
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
64
Applicant Total
25
Review Days
85
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Basic Information
- Device Name
- Twist Drills
- K Number
- K213208
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Microfixation
- Date Received
- September 29, 2021
- Decision Date
- December 23, 2021
- 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)
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UniBur
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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
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| 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 |
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