FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tactoset Injectable Bone Substitute
K Number: K212083
·
Decision Aug 31, 2021
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
491
Applicant Total
9
Review Days
60
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Basic Information
- Device Name
- Tactoset Injectable Bone Substitute
- K Number
- K212083
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Anika Therapeutics, Inc.
- Date Received
- July 2, 2021
- Decision Date
- August 31, 2021
- 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 Anika Therapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250997 | Integrity Implant | Jun 17, 2025 | Substantially Equivalent |
| K231968 | Tactoset® Injectable Bone Substitute | Dec 20, 2023 | Substantially Equivalent |
| K223538 | Integrity Implant | Aug 17, 2023 | Substantially Equivalent |
| K223860 | Integrity Bone Staple Fixation System | May 22, 2023 | Substantially Equivalent |
| K222487 | Anika Tissue Tack Fixation System | May 8, 2023 | Substantially Equivalent |
| K223915 | Tactoset | Mar 29, 2023 | Substantially Equivalent |
| K190956 | SCS 17-01 | Jan 30, 2020 | Substantially Equivalent |
| K173008 | SCS 17-01 | Dec 26, 2017 | Substantially Equivalent |