FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OsteoMed PINNACLE Driver
K Number: K162544
·
Decision Apr 4, 2017
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
8
Applicant Total
12
Review Days
204
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
- OsteoMed PINNACLE Driver
- K Number
- K162544
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteomed
- Date Received
- September 12, 2016
- Decision Date
- April 4, 2017
- Product Code
- KMW
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| KMW | Handpiece, Rotary Bone Cutting | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KMW), ordered by most recent decision date.
Oral Surgery Contra
FDA 510(k)
FDA Class 2
·Dental
Surgical Angle Handpiece, Surgical Straight Handpiece
FDA 510(k)
FDA Class 2
·Dental
SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
FDA 510(k)
FDA Class 2
·Dental
FRIOS MICROSAW
FDA 510(k)
FDA Class 2
·Dental
OSTEOPOWER SYSTEM AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Dental
E-TYPE SPEED REDUCER CONTRA ANGLE
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Osteomed
| K Number | Device Name | ||
|---|---|---|---|
| K203479 | ExtremiLOCK Lateral Ankle Fusion Plates | Feb 24, 2021 | Substantially Equivalent |
| K162542 | OsteoMed PINNACLE Driver | May 19, 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 |