FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE
K Number: K234013
·
Decision Feb 5, 2024
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
491
Applicant Total
8
Review Days
48
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Basic Information
- Device Name
- Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE
- K Number
- K234013
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bone Solutions, Inc.
- Date Received
- December 19, 2023
- Decision Date
- February 5, 2024
- Product Code
- MQV
- 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 |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | FDA class 2 | Orthopedic |
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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 |
| 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 |
| K161568 | Bone Solutions Mixing and Delivery System | Sep 16, 2016 | Substantially Equivalent |
| K071004 | OSTEOCRETE BONE VOID FILLER | May 21, 2009 | Substantially Equivalent |