FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OsteoMed PINNACLE Driver
K Number: K162542
·
Decision May 19, 2017
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
64
Applicant Total
12
Review Days
249
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Basic Information
- Device Name
- OsteoMed PINNACLE Driver
- K Number
- K162542
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteomed
- Date Received
- September 12, 2016
- Decision Date
- May 19, 2017
- 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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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
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Other Clearances by Osteomed
| K Number | Device Name | ||
|---|---|---|---|
| K203479 | ExtremiLOCK Lateral Ankle Fusion Plates | Feb 24, 2021 | Substantially Equivalent |
| K162544 | OsteoMed PINNACLE Driver | Apr 4, 2017 | Substantially Equivalent |
| K161041 | OsteoMed ExtremiLOCK Wrist Plating System | May 19, 2016 | Substantially Equivalent |
| K152145 | OsteoMed ExtremiLOCK Wrist Plating System | Dec 21, 2015 | Substantially Equivalent |
| K151195 | OsteoMed IMF Screw | Sep 21, 2015 | Substantially Equivalent |
| K140978 | OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM | Dec 18, 2014 | Substantially Equivalent |
| K140283 | OSTEOMED EXTREMIFUSE SYSTEM | Feb 28, 2014 | Substantially Equivalent |
| K131851 | OSTEOMED NEURO RONGEUR | Dec 6, 2013 | Substantially Equivalent |
| K133437 | 1ST MTP PLATE | Dec 2, 2013 | Substantially Equivalent |
| K130412 | OSTEOMED EXTREMIFUSE SYSTEM | May 31, 2013 | Substantially Equivalent |