FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
OsteoProbe
K Number: DEN210013
·
Decision Aug 19, 2021
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
3
Review Days
142
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Basic Information
- Device Name
- OsteoProbe
- K Number
- DEN210013
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 888.1600
- Medical Specialty
- Orthopedic
- Decision
- Unknown
- Applicant
- Active Life Scientific, Inc.
- Date Received
- March 30, 2021
- Decision Date
- August 19, 2021
- Product Code
- QGQ
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| QGQ | Bone Indentation Device | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QGQ), ordered by most recent decision date.
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