FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
K Number: K190172
·
Decision Jun 14, 2019
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
60
Applicant Total
86
Review Days
133
Basic Information
- Device Name
- Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
- K Number
- K190172
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker
- Date Received
- February 1, 2019
- Decision Date
- June 14, 2019
- 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
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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)
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