FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
K Number: K240175
·
Decision Oct 29, 2024
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
7
Review Days
280
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Basic Information
- Device Name
- Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
- K Number
- K240175
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tigon Medical
- Date Received
- January 23, 2024
- Decision Date
- October 29, 2024
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Tigon Medical
| K Number | Device Name | ||
|---|---|---|---|
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Apr 21, 2026 | Substantially Equivalent |
| K252596 | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | Dec 4, 2025 | Substantially Equivalent |
| K242529 | Tigon Medical All-Suture Anchors (ASA) | Dec 20, 2024 | Substantially Equivalent |
| K220464 | Tigon Medical Gryphon Anchor Line | Mar 22, 2023 | Substantially Equivalent |
| K211049 | Tigon Medical Button System | Aug 4, 2021 | Substantially Equivalent |
| K182507 | Tigon Medical Tissue Anchors | Jan 21, 2019 | Substantially Equivalent |