FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Bone Solutions Mixing and Delivery System
K Number: K161568
·
Decision Sep 16, 2016
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
8
Review Days
101
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Basic Information
- Device Name
- Bone Solutions Mixing and Delivery System
- K Number
- K161568
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bone Solutions, Inc.
- Date Received
- June 7, 2016
- Decision Date
- September 16, 2016
- Product Code
- FMF
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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Other Clearances by Bone Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE | Oct 13, 2025 | Substantially Equivalent |
| K242372 | Mg OSTEOREVIVE, Mg OSTEOCRETE | Oct 18, 2024 | Substantially Equivalent |
| K234013 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE | Feb 5, 2024 | Substantially Equivalent |
| K221256 | Mg OSTEOINJECT | Jun 28, 2022 | Substantially Equivalent |
| K212991 | Osteorevive | Jan 21, 2022 | Substantially Equivalent |
| K192674 | Mixing and Delivery System | Feb 18, 2020 | Substantially Equivalent |
| K071004 | OSTEOCRETE BONE VOID FILLER | May 21, 2009 | Substantially Equivalent |