FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Integrity Implant
K Number: K250997
·
Decision Jun 17, 2025
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
4
Applicant Total
9
Review Days
77
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Basic Information
- Device Name
- Integrity Implant
- K Number
- K250997
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Anika Therapeutics, Inc.
- Date Received
- April 1, 2025
- Decision Date
- June 17, 2025
- Product Code
- OWX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| OWX | Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OWX), ordered by most recent decision date.
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Integrity Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Anika Therapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K212083 | Tactoset Injectable Bone Substitute | Aug 31, 2021 | Substantially Equivalent |
| K190956 | SCS 17-01 | Jan 30, 2020 | Substantially Equivalent |
| K173008 | SCS 17-01 | Dec 26, 2017 | Substantially Equivalent |